FDA 483 - Hallettsville Pharmacy, LLC - November 08, 2018

During an FDA inspection conducted from November 5-8, 2018, Hallettsville Pharmacy, LLC, a producer of non-sterile drugs, received a Form FDA 483 detailing significant observations. The primary concerns revolved around two key areas. Firstly, the pharmacy was cited for inadequate cleaning procedures for work surfaces and utensils used in the production of highly potent drugs like Testosterone, Estriol, and Progesterone. Specifically, the firm lacked evidence to demonstrate that its cleaning methods effectively removed residual drug products or detergents, raising concerns about potential cross-contamination. Stained rubber spatulas further highlighted this issue. Secondly, the inspection noted the use of non-pharmaceutical grade components in drug formulations. The pharmacy utilized unvalidated water sources without sufficient testing data to prove that they met, at a minimum, the specifications for Purified Water USP. This was observed in drug products such as Lidocaine/Prilocaine/Tetracaine/Phenylephrine 2%. These observations indicate a need for Hallettsville Pharmacy to review and validate its cleaning protocols for potent drug manufacturing and ensure all components used in drug production meet appropriate pharmaceutical grade standards, supported by adequate testing. The FDA 483 prompts the company to implement corrective actions to address these deficiencies and ensure compliance with regulatory expectations for drug quality and safety.