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# Latest FDA Warning Letters
- URL: https://www.fdaweb.com/latest-fda-warning-letters-78/
- Published: 2016-08-16T12:00:00.000Z
- Updated: 2026-09-14T21:24:40.000Z
- Author: David McFarland
- Tags: FDA Policy/General, #legacy-id-D5136530

Today FDA posted its latest batch of Warning Letters. They can be accessed by clicking on the link following each letter.

**A.R.C.O.S. Srl** Travagliato, Brescia, Italy (8/3) Inspected 4/4-6\. QSR deviations, adulterated: The firm does not have written design control procedures, and has not conducted and documented design control activities for various models of compression socks. Also the firm does not have written complaint handling procedures and does not conduct investigations into complaints received directly or by its U.S. agent, etc. (compression socks, including Travelsox, Euros, Caresox, and Vitalsox); FDCA 501(h), 502(t)(2), 21 CFR 820.30(a), 820.198(a), 820.90(a), 820.70(a), 820.80(a), 820.20(c), 820.50, 820.100(a), 820.22, 820.250(a), 803.17  
[http://www.fda.gov/ICECI/EnforcementActions/WarningLetters/2016/ucm515195.htm](http://www.fda.gov/ICECI/EnforcementActions/WarningLetters/2016/ucm515195.htm?ref=fdaweb.com)

**Aussimed Ltd.** Neuried, Germany (3/3) Inspected 11/2-3/15\. QSR deviations, adulterated: The firm failed to establish procedures for design control for the CyberScan device and its response is inadequate in that it does not include documentation that demonstrates established design controls. Also, the firm failed to establish and maintain procedures for receiving, reviewing, and evaluating complaints by a formally designated unit, etc. (biofeedback devices); FDCA 501(h), 21 CFR 820.30(a), 820.50(a), 820.100(a), 820.198(a), 820.184  
[http://www.fda.gov/ICECI/EnforcementActions/WarningLetters/2016/ucm515471.htm](http://www.fda.gov/ICECI/EnforcementActions/WarningLetters/2016/ucm515471.htm?ref=fdaweb.com)

**Bedfont Scientific, Ltd.** Maidstone, United Kingdom (2/4) Inspected 9/7-10/15\. QSR deviations, adulterated: The firm failed to establish and maintain procedures for implementing corrective and preventive action. Its complaint handling procedures do not ensure that complaints are evaluated to determine if they represent an event which is required to be reported to FDA under 21 CFR 803, Medical Device Reporting. It also failed to ensure that when computers or automated data processing systems are used as part of production or the quality system, the manufacturer shall validate computer software for its intended use according to an established protocol, etc. (carbon monoxide monitors); FDCA 501(h), 502(t)(2), 21 CFR 820.100(a), 820.198(a), 820.30(g), 820.30(i), 820.50, 820.70(i), 820.250(b), 803.17  
[http://www.fda.gov/ICECI/EnforcementActions/WarningLetters/2016/ucm515647.htm](http://www.fda.gov/ICECI/EnforcementActions/WarningLetters/2016/ucm515647.htm?ref=fdaweb.com)

**Beyond Technology Corp.** Nanchang, China (7/19). Inspected 11/9-11/15\. QSR deviations, adulterated: The firm failed to establish and maintain procedures to prevent contamination of equipment or product by substances that could reasonably be expected to have an adverse effect on product quality. The buildings used in the manufacturing process were infested by rodents. Fresh excrement was observed on the bags of raw materials and on the windowsills in the (purged) room. There were no written training procedures to define job specific training requirements for manufacturing operators, etc. (teeth whitening devices and dental floss); FDCA 501 (h), 21 CFR 820.70(e), 820.90(a), 820.25(b)  
[http://www.fda.gov/ICECI/EnforcementActions/WarningLetters/2016/ucm515336.htm](http://www.fda.gov/ICECI/EnforcementActions/WarningLetters/2016/ucm515336.htm?ref=fdaweb.com)

**Centro Naturista** Frisco, TX (6/16) Inspected the firm’s own-label distribution facilities Centro Naturista in Dallas, TX and Smart Lipo in Arlington, TX. FDA confirmed through laboratory analysis that the Smart Lipo product contains undeclared sibutramine and phenolphthalein. Sibutramine is the active pharmaceutical ingredient in Meridia, withdrawn in 2010 after clinical data indicated sibutramine poses an increased risk of heart attack and stroke. Unapproved new drug, misbranded: The labeling for this drug fails to bear adequate directions for use, etc. (Smart Lipo); FDCA 505(a), 502(f)(1), 502(a), 502(j)  
[http://www.fda.gov/ICECI/EnforcementActions/WarningLetters/2016/ucm515915.htm](http://www.fda.gov/ICECI/EnforcementActions/WarningLetters/2016/ucm515915.htm?ref=fdaweb.com)

**C World KSG Corp.** Cavite, Philippines (2/18). Inspected 10/26-29/15\. QSR deviations, adulterated: The firm failed to establish and maintain procedures for monitoring and control of process parameters for validated processes to ensure that the specified requirements continue to be met. The required process parameters are not met for (purged) lots of contact lenses manufactured in (purged) and shipped to U.S. customers. The firm’s CAPA procedure does not include requirements for verifying or validating CAPAs to ensure that such actions are effective and do not adversely affect the finished device, etc. (contact lenses); FDCA 501(h), 21 CFR 820.75(b), 820.100(a), 820.198(a), 820.22  
[http://www.fda.gov/ICECI/EnforcementActions/WarningLetters/2016/ucm515524.htm](http://www.fda.gov/ICECI/EnforcementActions/WarningLetters/2016/ucm515524.htm?ref=fdaweb.com)

**F.P. Rubinstein Y Cia SRL** Cordoba, Argentina (5/5). Inspected 12/14-17/15\. QSR deviations, adulterated: The firm failed to establish and maintain procedures for implementing corrective and preventive action. This is a repeat observation from the inspection ending 10/17/14\. It also failed to establish and maintain procedures for receiving, reviewing, and evaluating complaints by a formally designated unit, etc. (laser powered surgical instruments); FDCA 501(h), 21 CFR 820.100(a), 820.198(a), 820.30(f)&(g), 820.75(a), 820.70(i), 820.70(c), 820.50, 820.72(a), 820.20(c), 820.184, 1040.10(c)&(g), 1002.13  
[http://www.fda.gov/ICECI/EnforcementActions/WarningLetters/2016/ucm515403.htm](http://www.fda.gov/ICECI/EnforcementActions/WarningLetters/2016/ucm515403.htm?ref=fdaweb.com)

**Helica Instruments, Ltd.** Edinburgh, UK (5/13). Inspected 11/9-11/15\. QSR deviations, adulterated, misbranded: The firm failed to establish and maintain adequate procedures to control product that does not conform to specified requirements. It also failed to establish and maintain procedures to ensure that the device design is correctly translated into production specifications. For example, the firm has no written procedures for design transfer. The firm does not have an approved PMA or IDE, etc. (electrosurgical cutting and coagulation device and accessories, including the Helica Thermal Coagulator); FDCA 501(h), 501(f)(1)(B), 21 CFR 820.90(a), 820.198(a), 820.30(c)(d)(e)&(f)&(g)&(h)&(i), 820.50, 820.100(a)  
[http://www.fda.gov/ICECI/EnforcementActions/WarningLetters/2016/ucm515393.htm](http://www.fda.gov/ICECI/EnforcementActions/WarningLetters/2016/ucm515393.htm?ref=fdaweb.com)

**Implants International Ltd.** Cleveland, UK (2/18). Inspected 8/24/27/15\. QSR deviations, adulterated: The firm received complaints of hip dislocation associated with implant products Cer-Met iii cup 50 mm and an XLP insert. Its CAPA procedure does not require analysis of quality issues, such as these complaints, for potential CAPA. The firm also failed to adequately ensure that when the results of a process cannot be fully verified by subsequent inspection and test that the process shall be validated with a high degree of assurance and approved according to established procedure, etc. (orthopedic implants); FDCA 501(h), 502(t)(2), 21 CFR 820.100(a), 820.75(a), 820.90(a), 820.30(c), 820.181, 803.17  
[http://www.fda.gov/ICECI/EnforcementActions/WarningLetters/2016/ucm515974.htm](http://www.fda.gov/ICECI/EnforcementActions/WarningLetters/2016/ucm515974.htm?ref=fdaweb.com)

**Master And Frank Ent. Co., Ltd.** Guangdong, China (5/10). Violations: FDA completed an evaluation of the firm’s corrections and corrective actions in response to a Warning Letter (CMS # 481365, dated 10/27/15). The firm failed to establish and maintain acceptance procedures, where appropriate, to ensure that specified requirements for in-process product are met. FDA reviewed the firm’s response and concluded that it is not adequate. It submitted a FMEA risk analysis for the surgical drapes and gowns, but it is not adequate as the firm did not consider all potential hazards. For example, the potential chemical, biohazardous, and physical contaminants that may become embedded or attached to fabric material of the surgical gowns and drapes are not properly characterized. It also failed to establish and maintain procedures for implementing corrective and preventive action, etc. (surgical drapes and gowns); 21 CFR 820.80(c), 820.100, 820.30(h)  
[http://www.fda.gov/ICECI/EnforcementActions/WarningLetters/2016/ucm516176.htm](http://www.fda.gov/ICECI/EnforcementActions/WarningLetters/2016/ucm516176.htm?ref=fdaweb.com)

**Mooncup LTD** Brighton, U.K. (5/27). Inspected 1/25-27\. QSR deviations, adulterated: The firm did not have design control procedures in place at the time the MCUK menstrual cup was designed and developed in 2002\. The firm failed to report to FDA no later than 30 calendar days after the day it received or otherwise became aware of information, from any source, that reasonably suggests that a device that it markets may have caused or contributed to a serious injury. For example, information in the complaint files for Note to File 510(k) IUD/01, signed 5/5/13, describes a patient’s intrauterine device being dislodged following removal of the Mooncup device, and the patient experienced an ectopic pregnancy and ruptured Fallopian tube, requiring surgical intervention, etc. (menstrual cups); FDCA 501(h), 502(t)(2), 21 CFR 820.30(a), 803.50(a)(1)  
[http://www.fda.gov/ICECI/EnforcementActions/WarningLetters/2016/ucm515375.htm](http://www.fda.gov/ICECI/EnforcementActions/WarningLetters/2016/ucm515375.htm?ref=fdaweb.com)

**Novastep** Saint-gréoire, France (7/28). Inspected 2/1-4\. QSR deviations, adulterated: The firm failed to define the type and extent of control to be exercised over the product, services, suppliers, contractors, and consultants, based on the evaluation results. The response dated 2/15 was not adequate. The firm did not evaluate the potential risk of nonconforming product being distributed, and actions required if nonconforming product was distributed. The firm documented (purged) supplier nonconformances for aspect, dimensional, labeling, and laser marking in 2014 and 2015, resulting in rework of (purged) products. However, there was no documentation of retesting and reevaluation of the products that were reworked, etc. (bone staples, screws, plates, and intermedullary implants); FDCA 501(h), 502(t)(2), 21 CFR 820.50(a)(2), 820.90(b)(2), 820.40, 803.50(a)(1), 803.17  
[http://www.fda.gov/ICECI/EnforcementActions/WarningLetters/2016/ucm515198.htm](http://www.fda.gov/ICECI/EnforcementActions/WarningLetters/2016/ucm515198.htm?ref=fdaweb.com)

**Noven Pharmaceuticals, Inc.** Miami, FL (8/5) Inspected 6/22-7/10/15\. GMP deviations, adulterated: The firm failed to establish and document the accuracy, sensitivity, specificity, and reproducibility of test methods. Also, the firm failed to record and justify any deviations from required laboratory control mechanisms, etc. (drugs); FDCA 501(a)(2)(B), 21 CFR 211.165(e), 211.160(a), 211.192, 211.180(e), 211.198  
[http://www.fda.gov/ICECI/EnforcementActions/WarningLetters/2016/ucm516222.htm](http://www.fda.gov/ICECI/EnforcementActions/WarningLetters/2016/ucm516222.htm?ref=fdaweb.com)

**Sentara Enterprises** Chesapeake, VA (8/8). Inspected 7/13-23/15\. Violations, adulterated: Investigators observed rust on HEPA filter grills and rusted vents of hoods used during aseptic production. The firm failed to demonstrate through appropriate studies that its aseptic processing areas are able to provide adequate protection of the ISO 5 areas in which sterile products are processed. FDA collected environmental samples at multiple locations in the firm, including the aseptic processing areas. Testing results of the samples identified microbial contamination in the aseptic processing areas, including spore-forming bacteria, etc. (drug products); FDCA 501(a)(2)(A)  
[http://www.fda.gov/ICECI/EnforcementActions/WarningLetters/2016/ucm515771.htm](http://www.fda.gov/ICECI/EnforcementActions/WarningLetters/2016/ucm515771.htm?ref=fdaweb.com)

**Shenzhen Creative Industry Co., Ltd.** Shenzhen, China (1/15). Inspected 8/3-6/15\. QSR deviations, adulterated: The firm failed to establish and maintain adequate procedures for implementing corrective and preventive action. It also failed to establish and maintain adequate procedures for documenting the disposition of nonconforming product, etc. (Class II patient monitors, fetal dopplers, and oximeters); FDCA 501(h), 21 CFR 820.100(a), 820.90(b)(1), 820.198(a), 820.30(g)  
[http://www.fda.gov/ICECI/EnforcementActions/WarningLetters/2016/ucm515685.htm](http://www.fda.gov/ICECI/EnforcementActions/WarningLetters/2016/ucm515685.htm?ref=fdaweb.com)

**Spiegelberg Gmbh & Co. KG** Hamburg, Germany (8/3). Inspected 2/1-4\. QSR deviations, adulterated: The firm failed to establish and maintain procedures for validating the device design. It also failed to establish and maintain procedures for implementing corrective and preventive action, etc. (intercranial pressure monitoring products, including the ICP Monitor HMO 29.1, ICP Monitor HOM 29.2, ICP 3PS Probe, and ICP Probe 3PN); FDCA 501(h), 502(t)(2), 21 CFR 820.30(g), 820.90(b)(1), 820.100(a), 820.70(i), 820.90(a).  
[http://www.fda.gov/ICECI/EnforcementActions/WarningLetters/2016/ucm515340.htm](http://www.fda.gov/ICECI/EnforcementActions/WarningLetters/2016/ucm515340.htm?ref=fdaweb.com)

**The Wellness Center Pharmacy, Inc., dba Designer Drugs** Chattanooga, TN ((8/5). Adulterated, misbranded: The inspection was conducted after receipt of a MedWatch report involving a patient who reportedly experienced an adverse event after being implanted with hormone replacement pellets produced by the firm. The investigator noted that the firm did not receive valid prescriptions for individually-identified patients for all of the drug products it was producing. Also, the firm produced domperidone drug products, which are not the subject of an applicable USP or National Formulary monograph, or a component of an FDA approved human drug product, etc. (drug products); FDCA 501(a)(2)(A), 502(f)(1)  
[http://www.fda.gov/ICECI/EnforcementActions/WarningLetters/2016/ucm515628.htm](http://www.fda.gov/ICECI/EnforcementActions/WarningLetters/2016/ucm515628.htm?ref=fdaweb.com)

**W & R Investments, LLC** Nashville, TN (8/5). Inspected 4/5-13\. QSR deviations, adulterated: There is no documentation of post-sterilization product performance testing for the UltraLaser Flexible CO2 Laser Waveguides. The firm failed to establish and maintain processes for verifying the device design, etc. (UltraLaser Flexible CO2 Laser Waveguide); FDCA 501(h), 21 CFR 820.30(g), 820.30(f), 820.184, 820.181, 820.50 (a), 820.90 (a)  
[http://www.fda.gov/ICECI/EnforcementActions/WarningLetters/2016/ucm515631.htm](http://www.fda.gov/ICECI/EnforcementActions/WarningLetters/2016/ucm515631.htm?ref=fdaweb.com)

**Zhejiang Medicine Co. Ltd. Xinchang Pharmaceutical Factory** Shaoxing, Zhejiang, China (8/4). Inspected 6/15-18/15\. GMP deviations, adulterated: The laboratory personnel conducted unofficial testing without appropriate documentation, justification, and investigation. FDA investigators found that analysts performed multiple gas chromatography (GC) analyses of (purged) samples for residual solvents. Analysts performed these unofficial analyses and recorded them in separate “R&D” folders before conducting the officially reported sample analyses. The original, unofficial analyses stored in separate R&D folders were not part of the official quality control records for the firm’s API, and it did not consider the results of these unofficial analyses to evaluate the quality of the API or make batch release decisions for numerous batches of API, etc. (active pharmaceutical ingredients); FDCA 501(a)(2)(B)  
[http://www.fda.gov/ICECI/EnforcementActions/WarningLetters/2016/ucm516163.htm](http://www.fda.gov/ICECI/EnforcementActions/WarningLetters/2016/ucm516163.htm?ref=fdaweb.com)