Today FDA posted its latest batch of Warning Letters. They can be accessed by clicking on the link following each letter.
Frazer, Henry A. Montgomery, AL (6/5). Inspected 9/24-10/3/12. The clinical investigator failed to ensure that the investigation was conducted according to the investigational plan. He also failed to prepare and maintain adequate and accurate case histories that record all observations and other data pertinent to the investigation on each individual administered the investigational drug or employed as a control in the investigation. 21 CFR 312.60, 312.62(b)
Jabones Pardo S.A. Madrid, Spain (8/22) Inspected 3/11-14. GMP violations, adulterated: The firm failed to test its products for the identity and strength of each active ingredient prior to release. The investigator obtained certificates of analyses for the drug products showing that it did not perform identity and strength testing for the release of these over-the-counter drug products. The stability procedure fails to specify the sample size for stability and the long-term stability storage conditions. Also the firm failed to perform assay testing during the stability study. The quality unit did not adequately ensure that the drug products released to the market were supported by appropriate stability data, etc. (drug products); 21 CFR 211.165(a), 211.84(d)(2), 211.166(a), 211.192, 211.68(a)
John Brasil Dairy Turlock, CA Inspected 7/3, 9, and 11. Adulterated: FDA’s investigation revealed that the dairy did not use (purged), oxytetracycline hydrochloride, and oxytocin as directed by their prescription label or approved labeling. Investigators also found that the dairy administered oxytocin to its dairy cows without following the dosage and duration of treatment as stated in the servicing veterinarian’s prescription, etc. (new animal drugs); 21 CFR 530.41(a)(13), 530.11(a)
Stewart Pharmaceuticals, Inc. (dba Stewart Compounding Pharmacy) Fayetteville, NC (8/21). Inspected 3/18-25. CGMP violations, adulterated, misbranded: The firm is producing drugs that do not fall within the exemptions for compounded drugs described in section FDCA 503A or within the agency’s exercise of enforcement discretion set forth in Compliance Policy Guide 460.200 on Pharmacy Compounding. FDA investigators noted that the sterile drug products were prepared, packed, or held under insanitary conditions, whereby they may have become contaminated with filth or rendered injurious to health, causing the drug products to be adulterated. Labeling fails to bear adequate directions for their intended uses, etc. (drug products); FDCA 502(f)(1), 501(a)(2)(B), 21 CFR 211.113(b), 211.28(a), 211.42(c)(10)(iv), 211.167(a), 211.165(a)
Sundial Herbal Products Bronx, NY (5/24). Inspected 10/4-11/15/12. Unapproved new drugs. GMP deviations, misbranded for dietary supplements. The Koromantee, Wood and Root Tonic, Asthma, Diabetics, and Hepatitis/Liver products are offered for conditions that are not amenable to self-diagnosis and treatment by individuals who are not medical practitioners and adequate directions cannot be written so that a layman can use the products safely for their intended uses. Labels fail to bear nutrition labeling, etc.. (Woman Back Tonic, Koromantee, Wood and Root Tonic, Arthritis, Asthma, Diabetics, Flu-Allergy Hayfever, Hepatitis/Liver, and Worms & Parasites); FDCA 505(a), 21 CFR 111.75(a)(1)(i), 111.70(e), 111.205(a), 111.255(a), 111.103, 111.570(b)(1), 111.27(a)(3)(v)