J. Strickland and Co – FDA 483, Nov 20, 2025

During an inspection conducted from November 17 to November 20, 2025, the U.S. Food and Drug Administration (FDA) issued a Form 483 to J. Strickland and Co., detailing significant observations regarding its manufacturing practices. The inspection, carried out under the Federal Food, Drug, and Cosmetic Act, highlighted several deficiencies impacting the quality and control of over-the-counter (OTC) drug products.

Key issues included a failure to adequately test incoming raw materials and active pharmaceutical ingredients for identity, with several components lacking essential identity verification tests such as infrared spectroscopy or chromatography before being used in marketed products. Furthermore, finished drug products were released for distribution without appropriate laboratory determination of the identity and strength of their active ingredients. Specific examples cited the release of drug products without required testing for active ingredients, and batch records lacking designated areas for such results.

The FDA also noted insufficient laboratory controls, including a lack of testing for objectionable microorganisms in certain ingredients, and the absence of growth promotion testing for microbiological media. Environmental monitoring procedures were found to be inadequate, lacking specific monitoring locations and investigation requirements for deviations. Finally, batch production records did not consistently include complete labeling control records, particularly specimens of all labeling used for each product batch. J. Strickland and Co. is required to address these observations by implementing comprehensive corrective actions to ensure compliance with regulatory standards for drug product quality and manufacturing.