FDA 483 - Ladd Family Pharmacy LLC - September 23, 2016

An FDA inspection of Ladd Family Pharmacy LLC, conducted from September 12 to September 23, 2016, revealed significant deficiencies in their manufacturing processes. The observations highlighted a lack of adequate controls necessary for ensuring drug product quality and safety, particularly for non-sterile drug products compounded for non-patient-specific prescriptions. Key violations included the absence of a written stability testing program to scientifically determine appropriate expiration dates, leading to arbitrary beyond-use dates for products like Bezocaine/Lidocaine/Tetracaine gel and Cantharidin solution. Investigators also noted inadequate cleaning of manufacturing equipment, specifically compounding hoods, where residues from previous products were found in joints and surfaces. Furthermore, the firm's procedures for preventing contamination were deficient; employees moved between compounding and general pharmacy areas without proper precautions. Lastly, there was an insufficient finished product testing program, lacking a systematic approach to ensure drug products met quality specifications prior to release. These observations indicate a need for the company to implement robust quality control systems, enhance facility and equipment sanitation protocols, establish clear contamination prevention measures, and develop a comprehensive product stability and testing program to ensure compliance with drug manufacturing standards.