Today FDA posted its latest batch of Warning Letters. They can be accessed by clicking on the link following each letter.
Aerscher Diagnostics, LLC Chestertown, MD (6/28). Inspected 1/18-19. QSR deviations, adulterated: The firm failed to establish and maintain procedures for implementing corrective and preventive action. Also, there is no documented procedure for handling complaints including requirements to ensure the evaluation of complaints to determine whether they represent an MDR reportable event. The firm has also failed to document procedures addressing the control of non-conforming product including identifying, evaluating, segregating, and disposing the non-conforming product, etc. (screening tests for the detection of fecal or gastric occult blood); FDCA 501(h), 21 CFR 820.100(a), 820.198(a), 820.90(a), 820.70(a) & (c)&(g)(1), 820.22, 820.80(e), 803.17 (CMS #178032)
Alpha Laboratories, Inc. Toronto, Ontario, Canada (5/5). Inspected 10/25-27/10. GMP violations, adulterated: The firm has not thoroughly investigated the failure of a batch or any of its components to meet its specifications whether or not the batch has already been distributed. The Quality Control Unit reviews and approves Certificate of Analysis containing OOS results, but without conducting any investigation. The inspection revealed that the procedure for Out-Of-specification Results (SOP-GEN-0008 Rev 4) is not followed, etc. (drug product components); FDCA 501(a)(2)(B), 21 CFR 211.192, 211.160(a)(b)(3)(4) (WL: 320-11-012)
BioSan Laboratories, Inc. Derry, NH (6/17). Inspected 12/6/10-1/25/11. GMP violations, adulterated, misbranded: The firm failed to conduct at least one appropriate test or examination to verify the identity of a dietary ingredient prior to its use. The quality control personnel released finished batches of dietary supplements that did not conform to product specifications. The written instructions in the firm’s master manufacturing records did not include corrective action plans to use when a specification is not met, etc. (Women Over 40 One Daily dietary supplements and Adrenal Response dietary supplements); FDCA 402(g)(1), 403, 21 CFR 111.75(a)(1)(i)., 111.123(b)(2), 111.77(a) and 111.113(b)(2), 111.210(h)(5), 111.140(b)(3), 111.260(j)(2)(ii), 403(q)(5)(F), 403(s)(2)(C), 403(y) (NWE-21-11W)
Mayer Laboratories, Inc. Berkeley, CA. (7/5). Inspected 1/24-2/11. Unapproved devices, adulterated: (Aqua Lube Personal Lubricant and the Kimono MicroThin Latex Condom with Aqua Lube); FDCA 501(f)(1)(B) (CMS# 167292)
Premium Gold Flax Products & Processing, Inc. Denhoff, ND (7/1). Reviewed Web sites at www.premiumgoldflax.com and www.FlaxHullLignan.com in May. The firm’s flax seed products are promoted for conditions that cause them to be unapproved new drugs. For example, a Web page makes the claim: “Golden flaxseed is also high in lignans, which aid in the prevention of cancer …”, etc. (flaxseed products); FDCA 505(a), 502(f)(1) (MIN 11 – 35)