Pacifico National, Inc. dba AmEx Pharmacy – FDA 483, May 31, 2019

Pacifico National, Inc. dba AmEx Pharmacy received an FDA Form 483 following an inspection from April 15 to May 31, 2019, revealing significant deviations from current Good Manufacturing Practices (cGMP). The outsourcing facility displayed critical deficiencies across multiple operational areas. Key issues included inadequate environmental monitoring in aseptic processing, such as discarding positive microbial growth plates, using non-sterile equipment in clean areas, and failing to ensure proper incubation for microbial detection. Cleaning and disinfection practices were also substandard, with visible contamination, damaged equipment, and delayed filter changes. The firm failed to adhere to procedures designed to prevent microbiological contamination, evidenced by improper aseptic techniques, insufficient viable air sampling, and deficient airflow studies and media fills. Additionally, the company lacked essential validation for aseptic and sterilization processes, including cleaning validations and assessments for hazardous material ingress. A significant concern was the deficient handling of approximately 287 consumer complaints since 2016, with 111 related to plunger non-advancement and 18 serious complaints, including endophthalmitis, that were not adequately investigated or reported to the FDA. Other observations highlighted inadequate stability testing to support product expiration dates, insufficient controls over component suppliers, and deficiencies in employee training for aseptic operations and visual inspection. The firm also lacked container closure integrity testing, established time limits for production phases, adequate protective apparel, proper control over labeling, and drug product reserve samples. The company must implement comprehensive corrective and preventive actions to address these systemic cGMP violations and ensure the quality and safety of its sterile drug products.