FDA 483 - Ladd Family Pharmacy LLC - July 30, 2019

This FDA Form 483 document outlines observations made during an inspection of a drug manufacturing facility. The facility is cited for several violations related to drug product formulation, water quality, and equipment cleaning.

Specifically, the inspection found that a non-pharmaceutical grade component was used in the formulation of a drug product. Additionally, the facility failed to demonstrate that the water used as a component of aqueous drug products meets the minimum requirements for USP Purified Water. An example provided is the use of (b)(4) water as a component for Acetaminophen Free 12mg/mL Liquid lot number 07102019:66@26.

Furthermore, the facility produced hazardous drugs without providing adequate cleaning of work surfaces and utensils to prevent cross-contamination. Finally, the inspection noted a failure to adequately clean non-dedicated equipment; for instance, an oxidizing agent was not used to clean non-dedicated equipment after compounding a testosterone-containing product. These observations indicate deficiencies in quality control and manufacturing processes that could impact product safety and efficacy.