D.S.C. Products, Inc. Muskegon, MI (7/9). Limited inspection 5/20-6/11/02. GMP deviations, adulterated: Company failed to have a quality control unit adequate to perform its functions and responsibilities as demonstrated by the number and type of inspectional observations. Representative samples of each shipment of each lot are not collected for testing or examination, and raw material sample compositing is not an acceptable practice. Written procedures do not define how process validation will be conducted or documented. Company failed to calculate actual yields and percentages of theoretical yield at the conclusion of each appropriate phase of manufacturing, processing, packaging, or hold of the drug product. There was no data available to establish that analytical methods used to assay finished products meet appropriate standards for accuracy and reliability, etc. (drug products); FDCA 501(a)(2)(B), 21CFR 211.22, 211.67, 211.84(d), 211.100, 211.103, 211.110, 211.115(a)(b), 211.160(a)(b), 211.165(d)(e), 211.180(e), 211.194(b)(e) (2002-DT-30)
http://www.fda.gov/foi/warning_letters/g3404d.pdf
Saiyid Rasheeq Wahid Baton Rouge, LA (6/27). Inspected 2/25-26/02. Unapproved new drug. Misbranded: Product appears to be intended to treat, cure, or mitigate diseases including AIDS and cancer. Other evidence that the product is intended for use as a drug is that Wahid requires patients to sign a document that implicitly represents this product as an adjunct or alternative to other therapies for the disease for which Wahid is treating them, etc. (Dr. Wahid’s herbal remedy, an alternative medicine); FDCA 502(f)(1), 505(a) (2002-NOL-34) http://www.fda.gov/foi/warning_letters/g3398d.pdf
Vision Laboratories DBA Eliot, ME (6/24). Misbranded: Claims such as “Continue using Epiclear twice a day, every other day until blemishes have disappeared and skin has healed,” make the product an unapproved new drug as defined in FDCA 201(g). Although the active ingredients in the product are not specifically identified on the product label, labeling distributed with the product promote the ingredients in the formula for acne treatment and none of the ingredients are permitted under the regulations for OTC acne products, etc. (Epiclear Liposomal Facial Remedy); FDCA 502(f)(1)(2), 505 (NEW-19-02W) http://www.fda.gov/foi/warning_letters/g3397d.pdf
