FDA 483 - Jack P. Herick, Inc. dba Glades Drugs - December 10, 2015

During an inspection conducted from November 23 to December 10, 2015, the FDA issued a Form 483 to Jack P. Herick, Inc., operating as Glades Drugs, a producer of non-sterile drug products. The inspection revealed significant deviations from regulatory standards for drug manufacturing.

Key observations included a failure to adequately examine incoming components; specifically, cholecalciferol (Vitamin D3) component labeling lacked concentration information, leading to incorrect assumptions about active ingredient strength in distributed products like Vitamin Supplement D3 capsules. Furthermore, the firm was found not to be testing finished drug products, including creams, ointments, gels, and capsules, for potency or microbial limits prior to release for distribution. Compounding these issues, Glades Drugs lacked established scientifically sound specifications for drug products, particularly for microbial limits in non-sterile topical preparations. Consequently, no testing was conducted for objectionable microorganisms in these non-sterile drug products before they were distributed.

These observations highlight critical deficiencies in quality control, product testing, and specification establishment, indicating a need for comprehensive corrective actions to ensure the identity, strength, quality, and purity of their drug products.