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# Warning Letters Posted 12/19 to 12/30
- URL: https://www.fdaweb.com/warning-letters-posted-12-19-to-12-30/
- Published: 2017-01-03T12:00:00.000Z
- Updated: 2026-09-14T21:57:12.000Z
- Author: David McFarland
- Tags: Drugs, #legacy-id-D5137610

***FDA Webview*** has posted Warning Letter summaries for letters released during our holiday break (12/19 to 12/30). They can be accessed by clicking on the link following each letter.

**Antibioticos do Brasil** Sao Paulo,Brazil (12/8): FDA inspected the firm’s manufacturing facility last April and cited significant GMP violations for finished pharmaceuticals. For example, the firm failed to use equipment in the manufacture, processing, packing, or holding of drug products that is of appropriate design, adequate size, and suitably located to facilitate operations for its intended use and for its cleaning and maintenance. The firm’s smoke studies were found to not support its assertion that it maintains unidirectional airflow for all aseptic operations. At times, the smoke volume was too low to accurately demonstrate airflow. Additionally, the firm failed to adequately document environmental monitoring. FDA notes that it cited significant GMP observations in a 2009 Warning Letter, and it recommends the firm retain a consultant qualified to evaluate its operations.  
[http://www.fda.gov/ICECI/EnforcementActions/WarningLetters/2016/ucm534320.htm](http://www.fda.gov/ICECI/EnforcementActions/WarningLetters/2016/ucm534320.htm?ref=fdaweb.com)

**Aplicare, Inc.** Meriden, CT (12/15) FDA inspected the firm 1/2016 and cited significant GMP violations for finished pharmaceuticals. For example, the firm failed to implement adequate microbial controls for your povidone-iodine drug products, which purport to be sterile. The firm also failed to test numerous product lots for sterility using USP <71> or an equivalent method. And the agency found that it does not manufacture povidone-iodine drug products in production areas with appropriate air cleanliness.  
[http://www.fda.gov/ICECI/EnforcementActions/WarningLetters/2016/ucm533993.htm](http://www.fda.gov/ICECI/EnforcementActions/WarningLetters/2016/ucm533993.htm?ref=fdaweb.com)

**Aurora Health and Nutrition Soldotna**, AK (12/1) FDA reviewed the firm’s Web site at www.aurorahealthandnutrition.com and determined that it takes orders for the following products: 5-HTP, Alpha Lipoic Acid, the Argentyn 23 product line, Artecin 90 Vegetarian Capsules, ChromeMate GTF 600, Cold Sore Rescue, Curcumin, Myomin, and Ozonated Olive Oil. FDA determined that the firm’s products are unapproved drugs based on labeling claims that suggest they are articles intended for use in the diagnosis, cure, mitigation, treatment, or prevention of disease.  
[http://www.fda.gov/ICECI/EnforcementActions/WarningLetters/2016/ucm533205.htm](http://www.fda.gov/ICECI/EnforcementActions/WarningLetters/2016/ucm533205.htm?ref=fdaweb.com)

**Baoying County Fukang Medical Appliance Co.** Jiangsu Province, China (12/8): FDA inspected the firm in June and a company representative refused to explain the microbiological testing processes used on certain products because they are trade secrets. FDA also cited the firm for not having written procedures for production or quality unit responsibilities. Additionally, the agency said the firm does not perform microbiological analysis of your final products prior to release to the U.S. market.  
[http://www.fda.gov/ICECI/EnforcementActions/WarningLetters/2016/ucm533225.htm](http://www.fda.gov/ICECI/EnforcementActions/WarningLetters/2016/ucm533225.htm?ref=fdaweb.com)

**Global Drug Supply** (12/6): FDA cited the firm for shipping to U.S. consumers unapproved drugs on behalf of Canadadrugs.com, an internet pharmacy where the agency says consumers purchase violative drug products. FDA physically examined packages imported to the U.S. by Global Drug Supply that were determined, based on shipping labels, prescription order forms, and product labeling to contain unapproved new drugs.

**Intega Skin Sciences** Laval, Quebec (12/15): FDA inspected the firm’s drug manufacturing facility in May and cited significant GMP violations for finished pharmaceuticals. For example, the firm failed to **i**nvestigate an out-of-specification result of 11,000 colony forming units/gram as part of its total aerobic microbial count for a certain lot that was released for distribution, or extend the investigation to other potentially effected lots. FDA found that the firm lacked critical procedures to ensure that is has a functional quality unit, including procedures for review of out-of-specification results, complaint handling, and change control. The agency also recommended that Intega retain a consultant to assist it in meeting GMP requirements.  
[http://www.fda.gov/ICECI/EnforcementActions/WarningLetters/2016/ucm534336.htm](http://www.fda.gov/ICECI/EnforcementActions/WarningLetters/2016/ucm534336.htm?ref=fdaweb.com)

**Isomeric Pharmacy Solutions, LLC** Salt Lake City, UT (12/12): FDA inspected the firm in June and noted that drug products produced failed to meet the conditions of section 503B on pharmacy compounding by an outsourcing facility to qualify for exemptions from certain provisions. FDA also found serious deficiencies in its practices for producing sterile drug products.  
[http://www.fda.gov/ICECI/EnforcementActions/WarningLetters/2016/ucm534129.htm](http://www.fda.gov/ICECI/EnforcementActions/WarningLetters/2016/ucm534129.htm?ref=fdaweb.com)

**Natura Bisse International S.A.** Barcelona, Spain (12/15): FDA inspected the firm in January 2016 and cited significant GMP violations for finished pharmaceuticals. FDA found that it did not test over-the-counter drug products for identity and strength prior to release, which was a similar finding in a 2013 inspection. The firm also failed to implement a stability testing program for any of its products, and it had no test data to support drug expiration dates. Additionally, the firm’s laboratory lacks appropriate controls over laboratory log sheets recording microbiology, physico-chemical and organoleptic test results. FDA noted the firm was placed on Import Alert 66-40 on 10/28.  
[http://www.fda.gov/ICECI/EnforcementActions/WarningLetters/2016/ucm534309.htm](http://www.fda.gov/ICECI/EnforcementActions/WarningLetters/2016/ucm534309.htm?ref=fdaweb.com)

**Nomax Inc.** Saint Louis, MO (12/15): FDA inspected the firm in October and cited GMP and Quality System violations associated with its devices. For example, the firm failed to review, evaluate, and investigate quality complaints involving a Class II device (Pink and Green FlatPacks: a container for soft, gas permeable and hard contact lenses case used during chemical disinfection and storage) bleeding into contact lenses (discoloring the contact lenses). Also, the firm failed to review and document the suitability and effectiveness of the quality system at defined intervals. And, the firm failed to document acceptance activities for the FlatPacks, and it failed to maintain a Device History Record (DHR) for the device.  
[http://www.fda.gov/ICECI/EnforcementActions/WarningLetters/2016/ucm534145.htm](http://www.fda.gov/ICECI/EnforcementActions/WarningLetters/2016/ucm534145.htm?ref=fdaweb.com)

**Zyno Medical** Natick, MA (12/5): FDA inspected the firm in August and cited GMP and Quality System violations involving manufactured infusion pumps. For example, the firm failed to establish and maintain procedures for receiving, reviewing, and evaluating complaints by a formally designated unit. The firm was also cited for failing to analyze processes, work operations, concessions, quality audit reports, quality records, service records, complaints, returned product, and other sources of quality data to identify existing and potential causes of nonconforming product or other quality problems.  
[http://www.fda.gov/ICECI/EnforcementActions/WarningLetters/2016/ucm533240.htm](http://www.fda.gov/ICECI/EnforcementActions/WarningLetters/2016/ucm533240.htm?ref=fdaweb.com)