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Latest Warning Letters


Today FDA posted its latest batch of Warning Letters. They can be accessed by clicking on the link following each letter.

Andi International Freeport, NY (6/25) Adulterated: The firm markets hyperbaric chamber accessories in the U.S. without marketing clearance or approval. (LP Breathing-Air Supply Compressor, Oxygen Concentrators & Accessories, etc.); FDCA 501(f)(1)(B)

Chungdo Pharm. Co. Ltd. Chuncheon, Republic of South Korea (7/30). Inspected 3/4-3/7. QSR deviations, adulterated: The firm failed to establish and maintain procedures for implementing corrective and preventive action and to document all activities required. It also failed to establish and maintain procedures to control product that does not conform to specified requirements, etc. (Chemview-10TM Urinalysis Test Strips and Chemview-11); FDCA 501(h), 21 CFR 820.100(a) and (b)

LumiQuick Diagnostics Inc. Santa Clara, CA (7/31). Inspected 11/26-12/7/12. Adulterated, misbranded: The firm does not have approved applications for PMA or approved applications for investigational device exemptions. It also fails to maintain any written MDR procedures. (QuickView PSA, Syphilis Antibody, Rotavirus Antigen, and Troponin I Test Cards); FDCA 501(f)(1)(B), 502(o), 21 CFR 803.17

Natural Products Services, Inc. Escondido, CA (7/23) GMP violations, adulterated, unapproved new drugs: The firm did not conduct at least one appropriate test or examination to verify the identity of every component that is a dietary ingredient, to determine whether specifications are met. It also failed to prepare and follow a written master manufacturing record for each unique formulation of dietary supplement that it manufactures, and for each batch size, to ensure uniformity in the finished batch from batch to batch, etc. (CircuForce, HealthForce Liver Rescue 4+, HealthForce Scram, Healthforce Nopal Blood Sugar)

N.V.E. Pharmaceuticals, Inc. Andover, NJ (7/22) GMP deviations, adulterated, misbranded: From 10/2011-6/2012 the firm received 29 health related complaints, including a complaint of a heart attack, a possible allergic reaction, jittery, sick feeling, and a rash. The firm was unable to provide all this information to FDA investigators as required for product complaints. The firm failed to establish required specifications for points, steps, or stages in the manufacturing processes where control is necessary to ensure the quality of the dietary supplement. It manufactured dietary supplements without verifying the identity of the dietary ingredients used in your products. It failed to use sanitary handling procedures during filling, packaging, and labeling operations, etc. (Stacker 2-6 Hour Power, Stacker 2- Herbal Dietary Supplement, Stacker 2 Sleep Ease, etc.); FDCA 402(g)(1), 21 CFR 111.70(b)

Ontex Hygieneneartikel Gmbh Grospostwitz, Germany (8/1) Inspected 4/8-11. QSR deviations, adulterated, misbranded: The firm does not have written validation procedures for the tampon manufacturing process. Its production parameters are being implemented based on historical knowledge. The firm does not have formal documentation of acceptance criteria available to assure production of acceptable products. It also failed to maintain complaint files and establish and maintain adequate procedures for receiving, reviewing, and evaluating complaints by a formally designated unit, etc. (tampons and applicators); FDCA 501(h), 502(t)(2), 21 CFR 820.75(a)&(b), 820.30(a), 820.90(b)(2), 820.198(a)&(c), 820.250(b), 820.25(b)

Peter Schiff Enterprises Cookeville, TN (7/31). Inspected 3/22-4/12. QSR deviations, adulterated: The firm failed to establish finished device acceptance procedures. For example, there is no assurance each product batch of finished electrode pad met acceptance criteria prior to being released for distribution. It also failed to perform quality audits and to establish procedures for management review, etc. (AC fibrillators, unclassified devices, and silicone-based electrode pads); FDCA 520(f)(1), 501(h), 21 CFR 820.80(d), 820.100(a), 820.22, 820.40, 820.20(c)

Wonjin Mulsan Co., Ltd. Namdong-gu, INCHEON, S. Korea, Republic of (7/31) Inspected 4/1-4/4. QSR deviations, adulterated: The firm failed to establish and maintain design validation procedures to ensure that devices conform to defined user needs and intended uses. The firm’s response is not adequate in that the corrective action plan proposed does not address the systemic corrective action, the correction, and the corrective action. The firm also failed to document the corrective and preventive action activities and their results, etc. (POWER-Q1000 Compressible Limb Therapy System (Model WHF-314)); FDCA 501(h), 21 CFR 820.30(g), 820.100(a)(4), 820.100(b), 820.198(a)&(c), 820.80(b), 820.184