FDA has posted latest batch of Warning Letters. They can be accessed by clicking on the link following each letter.
Fujifilm Corp. Kanagawa, Japan (8/12). Inspected Kanagawa, Japan facility 4/23-5/1. Inspected Ibaraki Japan facility 4/13-4/20. Inspected Tochigi, Japan facility 4/20-22. Inspected Wayne, NJ facility 3/24-4/9. QSR deviations, adulterated, misbranded: The firm failed to establish and maintain procedures to control the design of the device in order to ensure that specified design requirements were met. For example in Miyanodai the firm’s 2014 reprocessing validation for the model ED-530XT duodenoscope did not include evaluating the effects of reprocessing on the O-ring. It conducted one full cycle run of ethylene oxide sterilization for validation, but did not justify how one full run is indicative of the process being consistent and reproducible. Also, the firm did not follow its “Complaint Handling for Medical Device” procedure, etc. (endoscopes and endoscope accessories); FDCA 501(h), 502(t)(2), 21 CFR 820.30, 820.100(a), 820.80(b), 820.75(a), 820.198(a), 820.50, 820.72(a), 820.70(a)
Hoya Corporation (PENTAX Life Care Division) Tokyo, Japan (8/12). Inspected Tokyo, Japan facility 4/13-21. Inspected Miyagi, Japan 4/22-24. Inspected Pentax of America 3/31-4/2. QSR deviations, adulterated, misbranded: The validation studies conducted to support the EtO sterilization and cleaning and high level disinfection Instructions for Use for the currently marketed device, ED-3670TK, were conducted using different model/series endoscopes and the firm failed to document why design validation results for the different model/series endoscopes are valid and applicable to the ED-3670TK devices [Akishima-shi, Tokyo]. The firm failed to establish and maintain procedures for implementing corrective and preventive action, etc. (endoscopes and endoscope accessories); FDCA 501 (h), 502(t)(2), 21 CFR 820.30(f)&(g), 820.100(a), 820.75(a), 803.50(a)(1), 803.17
Mylan Canonsburg, PA (8/6). Inspected three facilities in 2/6-13 in Bangalore, 9/23-10/3/14 in Bangalore, and 8/1-8/14 in Bangalore, Karnataka. CGMP deviations, adulterated: The firm failed to establish and follow appropriate written procedures that are designed to prevent microbiological contamination of drug products purporting to be sterile, and that include validation of all aseptic and sterilization processes. Non-integral (purged) gloves were used in Suites (purged) for conducting aseptic processing operations. Aseptic garments worn in the filling area were also non-integral, etc. (finished pharmaceuticals); FDCA 501(a)(2)(B), 21 CFR 211.113(b), 211.160(b)
MWT Materials, Inc. Passaic, NJ (8/6). Inspected 4/22-28. QSR deviations, adulterated: The firm has not established procedures for complaint handling or design history file(s) for Accusorb MRI devices. It has also failed to adequately maintain a device master record, etc. (Accusorb MRI devices, such as blankets and body-part shielding covers, for use during Magnetic Resonance Imaging); FDCA 501(h), 502(t)(2), 21 CFR 820.198(a), 820.30(j), 820.181, 803.17, 806.10(a)(1).
Olympus Medical Systems Corp. Tokyo, Japan (8/12). Inspected Tokyo, Japan facility 4/20-24, Fukushima, Japan facility 4/13-17, Center Valley, PA facility 3/25-4/1, San Jose, CA facility 3/19-4/2. QSR deviations, adulterated: The firm failed to report to FDA no later than 30 calendar days after the day that it received or otherwise became aware of information, from any source, that reasonably suggests that a device marketed by Olympus may have caused or contributed to a death or serious injury. For example, Complaint #GIR/OBV-11055 references 16 patients who contracted a Pseudomonas aeruginosa infection, of which some resulted in abscesses, after undergoing an endoscopic procedure with the firm’s devices. Olympus submitted one MDR to account for all the patients involved in the event and failed to submit an initial MDR for each event referencing patients sustaining abscesses as a result of contracting a Pseudomonas aeruginosa infection after undergoing an endoscopic procedure involving the firm’s devices, etc. (endoscopes and accessories); 21 CFR 803.50(a)(1), 803.17(a)(3)
Prime Health Products Toronto, Ontario, Canada (7/29). Reviewed Web site at www.sensiblehealth.com,. Also inspected facility 9/8-10/14. Unapproved new drugs, GMP deviations, misbranded: The claims on the Web site establish that the products are drugs because they are intended for use in the diagnosis, cure, mitigation, treatment, or prevention of disease. For example, the site claims: “Prime Health Products manufactures a unique collection of all-natural Chinese herbal tinctures for chronic health problems without using drugs... gallbladder problems and gallstone removal... endometriosis... insomnia, arthritis, thyroid disorders, allergies...” The firm failed to establish specifications for the identity, purity, strength, and composition of the finished batch of each dietary supplement that you manufacture, etc. (Liver/Gallbladder Flush 4-Pack, Chinese Bitters, Gold Coin Grass (GCG), Coptis, Curcuma, Chrysanthemum, Meta Plus, Shou Wu Tea, Taheebo Tea, Kidney Tea, Plantago Seeds, Black Sesame Seeds, and Boat-Fruited Sterculia Seeds); FDCA 505(a), 502(f)(1), 21 CFR 111.70(e), 111.75(c), 111.70(b)(2), 111.255, 111.260, 111.70(e) and (g), 403(y), 403(q)(5)(F), 403(q)(l)(A), 403(s)(2)(A)&(C)
Stat Medical Devices, Inc. N. Miami Beach, FL (7/23). Inspected 2/18-2/20. QSR deviations, adulterated: The firm’s Corrective and Preventive Action procedures lack documentation of root cause, impact on material and/or finished device, and corrective or preventive action under Section B, as required by its procedure. Also, the firm did not maintain documentation of sterilization validation to demonstrate that the current sterilization process is adequate and does not adversely affect the finished device and its packaging. It failed to adequately establish procedures to ensure that all purchased or otherwise received product and services conform to specified requirements, etc. (Blood Lancets, including the STAT Comfort Thins/Sterile Lancets; the STAT Lite & Ultimate Lancing Devices; the STAT Pedi-Let/Infant Heel–Blade; Blood Sampling Devices; and the STAT Auto/Clinical Safety Lancets); FDCA 501(h), 21 CFR 820.100(b), 820.75(a)&(b), 820.50, 820.198(a)
Transdermal Cap Inc. Cleveland, OH (8/10). Inspected 6/11-30. QSR deviations, adulterated: From 11/9/2014-5/25, a total of 125 complaints were received and documented informally in e-mails and on a spreadsheet. According to the firm’s Complain Handling procedure, Complaint form, #211.2.A should have been completed for each of these complaints, but was not. Data sources were not analyzed to identify existing and potential causes of nonconforming product or other quality problems, etc. (LaserCap); FDCA 501(h), 21 CFR 820.198(a), 820.100(a), 820.90(a), 820.30(f)&(g)