American Specialty Pharmacy, Inc. dba ASP Cares – FDA Warning Letter, Aug 23, 2018

On April 5, 2021, the FDA issued a Warning Letter to American Specialty Pharmacy, Inc. dba ASP Cares, an outsourcing facility registered under section 503B of the FDCA. An inspection from August 14-23, 2018, revealed serious deficiencies in sterile drug production and non-compliance with 503B conditions, rendering their drug products adulterated, unapproved new drugs, and misbranded.

Violations included: - **Failure to meet 503B conditions:** Inadequate adverse event reporting procedures, specifically lacking definitions for "serious" and "unexpected" adverse events, leading to loss of exemptions from drug approval, adequate directions for use, and DSCSA requirements. - **Adulterated Drug Products (Insanitary Conditions):** Failure to perform adequate dynamic smoke studies, media fills not simulating challenging conditions, facility disrepair (e.g., cracked caulking in ISO 7 cleanroom), and failure to document/measure pressure differentials. - **Adulterated Drug Products (CGMP Violations):** Failure to establish and follow procedures to prevent microbiological contamination, inadequate investigation of discrepancies, lack of written production/process control procedures reviewed by quality control, and failure to perform final product release testing for identity and strength.

While some corrective actions were noted (e.g., media fills, smoke studies, SOP revisions, pressure monitoring), others were deemed inadequate or lacking