FDA WARNING_LETTER - Med Shop Total Care, Inc. - July 27, 2021

On March 18, 2022, the FDA issued a Warning Letter to Med Shop Total Care, Inc. following an inspection from July 7 to July 27, 2021, which revealed serious deficiencies in sterile drug product production. The firm's practices led to drug products being prepared, packed, or held under insanitary conditions, rendering them adulterated under Section 501(a)(2)(A) of the FDCA.

Specific violations included: 1. Inadequate product evaluation and corrective action after microbial contamination in the ISO 5 aseptic processing area. 2. An operator placing gloved hands outside the ISO 5 area without sanitizing before re-entry. 3. Failure to establish adequate contact time for a disinfecting agent in aseptic processing areas. 4. Brownish residue on the HEPA filter screen within the ISO 5 area.

The FDA found the firm's August 17, 2021, response to the Form FDA 483 deficient. The response to Observation 1 was inadequate as it did not thoroughly assess the impact and duration of contamination in the ISO 5 area, and the firm's reliance on passing sterility tests for products compounded under insanitary conditions was rejected. The response to Observation 5 lacked a timeframe for implementing corrective actions regarding computer keyboards in the cleanroom.

The FDA strongly recommended a comprehensive assessment of operations, particularly aseptic processing, with assistance