Today FDA posted its latest batch of Warning Letters. They can be accessed in Adobe PDF format by clicking on the link following each letter.
AJP Scientific Clifton, NJ (3/2). Inspected 1/19-26. GMP deviations, adulterated: The firm has not established procedures to analyze and document quality data to identify and investigate existing or potential causes of nonconforming products or other quality problems. The firm also failed to document any CAPA activities and their results. The device master record for the Fetal Hemoglobin Stain device failed to include or refer to the location of all device specifications, production process specifications, quality assurance procedures, packaging and labeling specifications, and installation, maintenance, and servicing procedures and methods as required, etc. (Fetal Hemoglobin Differential Staining Kits and Semen Analysis Kits); FDCA 501(h), 502(t)(2), 21CFR 820.100(a), 820.198(a), 820.20, 820.90(a), 820.181, 820.50, 820.80(b), 803 (06-NWJ-10)
Devinney, Dennis Tyler, TX (4/21). Inspected 1/9-23. Clinical investigator violations: Investigator failed to obtain proper informed consent prior to any study related procedures. Investigator implanted three subjects with unapproved (purged) that were not part of the investigational plan. He also enrolled subjects that did not meet the inclusion/exclusion criteria. There was no documentation that the sponsor and IRB approved of these deviations, etc. (device study); 21CFR 50.20, 50.27(a), 812.100, 812.140(a)(3)(I), 812.100, 812.110(b), 812.150(a)(1), 812.140(a)(3) (No Code)
Hardie Farms, Inc. Lansing, NY (4/13). Investigated 12/7 and 12/13/05. Adulterated: Partner treated a dairy cow with Agri-cillin Procaine Penicillin G in a manner contrary to its approved labeling. The daily dosage level was not followed, nor did the administrator follow the duration of treatment or dosage level per injection site requirements set forth in the approved labeling. It was also administered without the supervision of a licensed veterinarian, etc. (Agri-cillin Procaine Penicillin G); FDCA 501(a)(5), 21CFR 530.11(a) (NYK 2006-15)
Teftec Corp. San Antonio, TX (4/24). Inspected 2/6-3/10. QSR deviations, adulterated, misbranded: The firm did not ensure adequate staffing to handle customer complaints or adequate employee training to handle the complaints. The staff was not trained on how to differentiate between a service call and a complaint. The complaint handling deficiencies were a repeat offense from a previous inspection. The service technician told the FDA investigator that he forwarded all customer calls to his management for review. But the firm does not explain why adequate descriptive details of each customer call were not documented after management review and how the current quality assurance manager will handle all customer calls by himself. The firm failed to adequately establish and maintain procedures for the identification, documentation, validation or verification, review and approval of design changes before their implementation, etc. (OmegaTrac and BetaTrac powered wheelchairs); FDCA 501(h), 502(t)(2), 21CFR 820.20, 820.198(a), 820.30(b)(e)(i), 803.17, 803.18 (2006-DAL-WL-20)
