Today FDA posted its latest batch of Warning Letters. They can be accessed by clicking on the link following each letter.
West Covina, CA (3/29). Inspected 8/11-9/29/15. Clinical investigation violations: The investigator failed to ensure that the investigation was conducted according to the investigational plan. He also failed to follow the protocol for subject eligibility when he enrolled Subject L-36, who did not have a measurable tumor at baseline. The investigator failed to maintain adequate and accurate case histories that record all observations and other data pertinent to the investigation on each individual administered the investigational drug or employed as a control in the investigation, etc. (investigational drug study); 21 CFR 312.60, 312.62(a)&(b)
Markopoulo, Greece (3/4). Inspected 10/5-8/15. QSR deviations, adulterated: The firm failed to establish and maintain procedures for receiving, reviewing, and evaluating complaints by a formally designated unit. The firm’s procedure, "Corrective and Preventive Action," SOP-12, does not include adequate requirements for: analyzing quality data to identify causes of nonconforming product or other quality problems, using appropriate statistical methodology, when necessary or for verifying or validating corrective and preventive actions to ensure they do not adversely affect finished devices, etc. (dental impression materials and composite resins); FDCA 501(h), 21 CFR 820.198(a), 820.100(a), 820.75(a), 820.72(a), 820.30(f)&(g), 820.250, 820.30(c)&(e), 820.22, 820.184
Brooklyn, NY (3/21). Inspected 4/9-4/23/14. Violations, adulterated, misbranded: The investigators observed that environmental monitoring for viable air in the ISO 5 zone is not performed. Also the firm does not have a routine program for daily monitoring of operators’ gloves. It 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. Some of the facility’s drug products do not include the following information on the product labels: the dosage form, phone number and address of the facility, and the statements "Office Use Only," "Not for Resale," and "This is a compounded drug," etc. (compounded drugs); FDCA 503B(b), 502(f)(1), 501(a)(2)(A)(B), 21 CFR 211.113(b), 211.42(c)(10)(iv), 211.28(a), 211.167(a)
Greenville SC (3/23). The firm failed to fulfill its listing obligations. A review of the listing for guaifenesin and codeine phosphate 100 mg/10 mg per 5 ml reveals that the product’s listing does not include a copy of the label. This product’s carton label is not uploaded into FDA’s Electronic Drug Registration and Listing System as part of the drug listing file. The unique facility identifier provided on the listing SPL also does not correspond with a currently registered establishment. (guaifenesin and codeine phosphate); FDCA 510(j)
Mumbai, Maharashtra, India (4/14). Inspected 3/16-23/15. GMP deviations, adulterated: During the inspection the investigator found a torn sheet of paper titled "Product Quality Complaints" on the floor of the warehouse. FDA compared it to the firm’s official complaint log and discovered that only two of the 17 customer complaints on the torn sheet were recorded in the firm’s official complaint log. The firm failed to review and investigate all production deviations. The firm’s computer system for entering test results and storing certificates of analysis (CoA), which document whether a drug meets specifications, does not have sufficient controls to prevent unauthorized changes to a CoA after quality unit approval, etc. (active pharmaceutical ingredients); FDCA 501(a)(2)(B)