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Latest FDA Warning Letters

FDA today posted its latest batch of Warning Letters. They can be accessed in Adobe PDF format by clicking on the link following each letter.

Abbott Laboratories Abbott Park, IL (9/24). Inspected 6/18-7/24/02. GMP deviations, adulterated: Abbott failed to conduct a thorough investigation when a batch or any of its components fail to meet specifications. For example, during the production of lot #79298AF00, black magnetic particulates were observed in granulation. Corrective action was taken to recondition the granulation to eliminate the particles, but no validation study was performed to establish that this procedure would successfully eliminate all of the particles. Abbott also failed to have adequate written procedures for production and process control to assure that drug products have the identity, strength, quality and purity they purport or are represented to possess. A tablet lot #79298AF00 was one of the batches included in the process validation study for this product, but the lot was not produced using the manufacturing process discussed in the validation study protocol. The lot was also subjected to several reconditioning steps, due to particulate contamination, that were not listed in the master batch record, etc. (erythrocin stearate tablets, etc.); FDCA 501(a)(2)(B), 21CFR 211.192, 211.100(a), 211.67(a) (CHI-25-02)


Choyang Medical Co., Ltd. Chungnam, Republic of Korea (11/22). Adulterated, misbranded: Unapproved medical devices (Choyang Dana Massager CY5000, Choyang Dana CY2000, Choyang Dana CY1000, Choyang Dana JO EUN A CIM (deluxe), and Choyang Dana EUN A CIM (regular)); FDCA 501(f)(1)(B), 502(o) (No Code)


Higher Power Nutrition Boise, ID (11/13). Unapproved new drugs. Products cannot be dietary supplements because they are not intended for ingestion since they are topical or intranasal products that are intended to bypass the alimentary canal by direct absorption through the skin or nasal mucosa; (Higher Power Nutrition Test-4 Blast, TestroGel, Deca Derm, MedLean Andro Sports Crème, and Pharmalogic XRX Androgenx Nasal Andro) FDCA 505 (SEA 03-03)


Walgreen Company Deerfield, IL (11/4). Unapproved new drug, based on the cough suppressant claim, “Ice Blue Flavored Menthol Cough Suppressant Drops.” (cough suppressant); FDCA 505 (CHI-28-03)