Today FDA posted its latest batch of Warning Letters. They can be accessed by clicking on the link following each letter.
9mm Special Effects Kahului, HI (5/19). Inspected 9/8-30/14. QSR deviations, unapproved device, adulterated, misbranded: The firm failed to establish and maintain procedures for implementing corrective and preventive actions. It also failed to develop, conduct, control, and monitor production processes to ensure that a device conforms to its specifications, etc. (contact lenses); FDCA 502(o), 502(t)(2), 501(f)(1)(b), 501(h), 21 CFR 820.100, 820.30(a), 820.75(a), 820.70(a), 820.20(e), 820.50, 820.140, 803
http://www.fda.gov/ICECI/EnforcementActions/WarningLetters/2015/ucm448437.htm
HHCS Pharmacy, Inc., dba Freedom Pharmacy Orlando, FL (5/14). Inspected 7/14/28/14. GMP deviations, adulterated, misbranded: The investigators noted that the pharmacy was not receiving valid prescriptions for individually identified patients for a portion of the drug products that it was producing. The firm also failed to demonstrate through appropriate studies that its hoods are able to provide adequate protection of the ISO 5 areas in which sterile products are processed, etc. (drug products); FDCA 502(f)(1), 21 CFR 211.113(b), 211.42(c)(10)((iv-v), 211.42(c)(10)
http://www.fda.gov/ICECI/EnforcementActions/WarningLetters/2015/ucm448689.htm
Insightra Medical, Inc. Irvine, CA (5/21). Inspected 2/19-24. QSR deviations, adulterated, misbranded: The firm failed to adequately establish procedures for receiving, reviewing, and evaluating complaints by a formally designated unit. The firm’s MDR procedure omits definitions of the terms “become aware,” and “caused or contributed,” found in 21 CFR 803.3 and the definition for the term “reasonably suggests,” found in 803.20(c)(1). FDA says that the exclusion of the definitions for these terms from the procedure may lead the firm to make an incorrect reportability decision when evaluating a complaint that may meet the criteria for reporting under 21 CFR 803.50(a), etc. (intra-aortic balloon catheters and inguinal hernia implants); FDCA 501(h), 502(t)(2), 21 CFR 820.198(a), 803.17, 803.3
http://www.fda.gov/ICECI/EnforcementActions/WarningLetters/2015/ucm448708.htm
LiquidCapsule Manufacturing, LLC Tampa, FL (5/15). Inspected 9/22-10/20/14. GMP deviations, adulterated, misbranded: The firm failed to establish specifications for components used to manufacture its finished dietary supplement product EnergyXcentric capsules. It also failed to maintain documentation of how it qualified its suppliers of components other than dietary ingredients by establishing the reliability of the suppliers’ certificate of analysis through confirmation of the results of the suppliers’ test or examinations, etc. (dietary supplements); FDCA 402(g)(1), 21 CFR 111.70(b)(2), 111.75(a)(2)(ii)(C), 111.70(e), 111.75(a)(2)(ii)(E), 111.105(a), 111.205(a), 111.255(b)
http://www.fda.gov/ICECI/EnforcementActions/WarningLetters/2015/ucm448697.htm
Nuga Medical Co., Ltd. Gyeonggi-Do, Republic of Korea (12/24/14). Inspected 8/25-28/14. QSR deviations, adulterated: There are no requirements for documenting investigations of failures that occur during design validation. The firm failed to open CAPAs for six of seven quality issues identified as needing investigation, etc. (NM-7000, NM-2500, and NM-90 therapeutic heating and massaging devices); FDCA 501(h), 21 CFR 820.30(g), 820.100(a), 803, 820.30(f)(i), 820.80(c), 803.17
http://www.fda.gov/ICECI/EnforcementActions/WarningLetters/2014/ucm441956.htm
Pharmakon Pharmaceuticals Noblesville, IN (5/21). Inspected 4/2-8/14 after FDA received reports of adverse events (over-sedation) in neonatal infants who were administered midazolam that the firm labeled with an incorrect concentration. Violations, adulterated: Investigators observed technicians touching non-sterile surfaces with gloved hands and then performing aseptic manipulations without first re-disinfecting gloves. The firm failed to demonstrate through appropriate studies that its hoods are able to provide adequate protection of the ISO 5 area in which sterile products are processed. It also firm failed to carefully examine labeling materials issued for a batch for identity and conformity to the labeling specified in the batch production records, etc. (compounded drugs); FDCA 502(f)(1), 502(a), 21 CFR 211.125(b), 211.113(b), 211.42(c)(10)(vi), 211.28(a), 211.42(c)(10)(iv)(v)
http://www.fda.gov/ICECI/EnforcementActions/WarningLetters/2015/ucm448642.htm
Premier Pharmacy Labs, Inc. dba Rx Nations Weeki Wachee, FL (4/27). Inspected 4/16/14 and 12/18/14. The FDA investigator observed serious deficiencies in the firm’s practices for producing sterile drug products. It did not monitor throughout the day the air pressure differentials from the ISO 7 areas and the ante room to the surrounding non-classified area and only infrequently performed personnel monitoring of operators involved in the production of sterile drug products. During the inspection the investigator also noted that some of the facility’s drug product labels did not include the statement, “This is a compounded drug.” Etc. (compounded drugs); FDCA 503(b)
http://www.fda.gov/ICECI/EnforcementActions/WarningLetters/2015/ucm448677.htm
Soft Computer Consultants, Inc. Clearwater, FL (4/30). Inspected 1/5-15. QSR deviations, adulterated: The firm failed to adequately establish procedures for CAPA. Also, it was not analyzing all sources of quality data to identify existing and recurring quality problems, etc. (Class I/II software systems); FDCA 501(h), 21 CFR 820.100(a), 820.50, 820.30(e)(i), 820.22, 820.20(b)
http://www.fda.gov/ICECI/EnforcementActions/WarningLetters/2015/ucm448655.htm
VUAB Pharma a.s. Roztoky, Czech Republic (5/27). Inspected 6/9-13/14. GMP deviations, adulterated: The firm failed to adequately investigate and resolve all quality-related customer complaints, and to investigate other batches that may have been associated with specific failures. In January 2014, the firm received a customer complaint about microbial contamination of an API lot. The customer tested samples of this lot produced by VUAB and identified Clostridium sphenoides. During the customer complaint investigation, VUAB was unable to detect the contamination in the samples that the customer returned, etc. (active pharmaceutical ingredients); FDCA 501(a)(2)(B)
http://www.fda.gov/ICECI/EnforcementActions/WarningLetters/2015/ucm448433.htm
