Today FDA posted its latest batch of Warning Letters. They can be accessed by clicking on the link following each letter.
Asept Pak Inc. Malone, NY (8/7). Inspected 6/11-20. GMP violations, adulterated: The firm failed to adequately document corrective and preventive action activities and results. For example, in one lot of sterile sodium chloride 0.9% USP for wound irrigation, the firm’s contract laboratory reported findings of the microorganism Bacillus clausii. Two retests performed found sterile results and the lot was released, but the firm failed to initiate, conduct, and document any investigation in response to the microorganism found in the initial sample results including, but not limited to, disposition, root cause, and any corrective and preventative action. The firm also failed to document appropriate equipment qualifications (i.e. IQ and OQ) on compounding tanks prior to executing process and product specific performance qualifications, etc. (sterile sodium chloride 0.9% USP for wound irrigation, and sterile sodium chloride 0.9% for device irrigation); FDCA 501(h), 21 CFR 820.100(b), 820.30(g)&(j), 820.75(a) (NYK-2012-23)
http://www.fda.gov/ICECI/EnforcementActions/WarningLetters/2012/ucm314785.htm
Center for the Improvement of Human Functioning International, Inc. IRB New York, NY (7/3). Inspected 7/6-8/11. Violations: The IRB had no written procedures, and did not follow adequate written procedures for the IRB’s functions and operations. The IRB failed to prepare and maintain adequate documentation of IRB activities, including copies of all research proposals reviewed, approved consent documents, and progress reports submitted by investigators. During the inspection, the IRB chair indicated that it met twice per year and had been in business for over 20 years. However, the field investigator was only able to locate one set of meeting minutes dated 6/25/97, etc. (IRB); 21 CFR 56.108(a)&(b), 56.115(a)(1)&(a)(2)(4)&(5)(6) (12-HFD-45-06-01)
http://www.fda.gov/ICECI/EnforcementActions/WarningLetters/2012/ucm314889.htm
Compumedics Germany Gmbh Singen, Germany (8/1). Inspected 3/19-22. GMP deviations, adulterated: The firm failed to adequately ensure, when the results of a process cannot be fully verified by subsequent inspection and test, that the process is validated with a high degree of assurance and approved according to established procedure. It also failed to establish and maintain adequate procedures for implementing corrective and preventive action in that its procedure does not include requirements for appropriate statistical methodology where necessary to detect recurring quality problems; investigating the cause of nonconformities relating to product, processes, and the quality system; verifying or validating the corrective and preventive action to ensure that such action is effective and does not adversely affect the finished device; or implementing and recording changes in methods and procedures needed to correct and prevent identified quality problems, etc. (pulsed Doppler ultrasonic imaging diagnostic systems); FDCA 501(h), 21 CFR 820.75(a), 820.100(a), 820.30(b)&(e)&(g), 820.198(b), 820.198(e), 820.40, 820.184 (No code)
http://www.fda.gov/ICECI/EnforcementActions/WarningLetters/2012/ucm315305.htm\
Grato, Inc. Woodbine, IA (7/30). Inspected 3/14-25/11. GMP deviations, misbranded: Unapproved new drugs. The firm has failed to extend an investigation to other batches of the same drug product or other drug products that may have been associated with the specific failure or discrepancy. For example, the investigations failed to include a scientific rationale to justify the release of drug products that may have been contaminated with metal shavings, etc. (Vital Male Sexual Energy, Vital HGH Skin Hair Nails, Vital HGH Immune Booster, Vital HGH, TinnitusDX, Fibro Relief, and AR Arthritis.) FDCA 301(a) 502(a), 503(b)(4), 505(a)m 21 CFR 211.192, 211.198(b)(3), 211.84(d)(2)(3) (KAN 2012-11)
http://www.fda.gov/ICECI/EnforcementActions/WarningLetters/2012/ucm314702.htm
Innovacyn, Inc. Rialto, CA (7/23). Inspected 11/21-12/2/11. GMP deviations, adulterated: The QCU failed to investigate, or did not fully investigate complaints, in numerous documented instances. The firm has not established microbial specifications or conducted microbial testing on the purified water used in the formulation of your veterinary drug products. It conducts bioburden testing, but this test method fails to demonstrate microorganism recovery, etc. FDCA 501(a)(5), 501(a)(2)(B), 21 CFR 211.192, 211.160(b) (WL 28-12)
http://www.fda.gov/ICECI/EnforcementActions/WarningLetters/2012/ucm315117.htm
Royal King Infant Products Co., Ltd. Samutsakhon, Thailand (7/26). Inspected 4/30-5/3. QSR deviations, adulterated: The firm failed to establish and maintain adequate procedures for implementing corrective and preventive action. It also stated that no procedures have been established to address receiving, reviewing, and evaluating complaints. The firm stated that it has never filed a MDR, nor has it reviewed complaints for MDRs. It failed to establish and maintain procedures for verifying the device design to confirm that the design output meets the design input requirements, etc. (fluid-filled teething rings); FDCA 501(h), 21 CFR 820.75(a), 820.100(a), 820.198(a), 820.30(c)&(e)&(f)&(h), 820.90(a), 820.184, 820.181 (No code)
http://www.fda.gov/ICECI/EnforcementActions/WarningLetters/2012/ucm314860.htm
Shijiazhuang Pharma Group Zhongnuo Pharmaceuticals Co. Ltd. Shijiazhuang, China (6/14). Misbranded: The firm has not fulfilled its registration obligations under the FD&C Act. FDA records indicate that the firm has not registered the establishment within 2011 or 2012, but has continued to manufacture, prepare, propagate, compound, or process drugs that were being imported or offered for import into the U.S. during this time. (pharmaceuticals); FDCA 510(i)(1), 502(o), 510(j) (WL: 300-12-013)
http://www.fda.gov/ICECI/EnforcementActions/WarningLetters/2012/ucm315301.htm
