FDA 483 - Peoples Pharmacy, Inc. - December 07, 2017

An FDA inspection of Peoples Pharmacy, Inc. in Austin, TX, conducted from November 28 to December 7, 2017, identified significant deficiencies in the firm's production of non-sterile drug products. The inspection resulted in an FDA Form 483, detailing two primary observations related to quality and manufacturing controls.

First, the company was cited for using non-pharmaceutical grade components. This included water from an unvalidated system that lacked documented microbiological and analytical testing to confirm it met Purified Water, USP specifications. Additionally, Acetone CP grade, labeled for "technical use only," was utilized in drug product formulations, raising concerns about product purity and safety.

Second, the inspection noted inadequate measures to prevent cross-contamination, especially when producing hazardous or highly potent drugs. Specifically, investigators observed discolored, cracked, and damaged rubber spatulas used in the manufacturing process, which could compromise product integrity.

These observations indicate deviations from established Good Manufacturing Practices. Peoples Pharmacy, Inc. is required to provide a formal response to the FDA outlining the comprehensive corrective actions implemented or planned to address these critical issues and ensure compliance with regulatory standards.