FDA WARNING_LETTER - Intrathecal Compounding Specialist, LLC - February 14, 2019

On September 15, 2020, the FDA issued a Warning Letter to Intrathecal Compounding Specialists, LLC, following an inspection from February 6-14, 2019. The inspection revealed serious deficiencies in sterile drug product production, rendering products adulterated under FDCA Section 501(a)(2)(A).

Key violations include: 1. Producing and distributing sterile drugs during/after HVAC maintenance without cleaning/recertification. 2. Failing to maintain adequate pressure differentials between air quality areas. 3. Not routinely using a sporicidal agent in the aseptic processing area. 4. Media fills not performed under challenging conditions, lacking assurance of aseptic production. 5. Improper donning and reuse of gowning apparel, risking contamination. 6. Personnel exhibiting poor aseptic technique, such as leaning into the ISO 5 laminar flow hood.

The FDA reviewed the firm's responses but found them insufficient. For example, the firm did not provide sterility/endotoxin test results for all products made during HVAC repairs, nor an adequate evaluation of products from February 6, 2019, when temperature excursions occurred. Documentation for cleaning contact times was missing. The revised gowning procedure lacked specifics on sterile mask donning and an implementation timeframe, and did not address continued reuse of gowns or poor aseptic technique. Media fill procedures remained unrepresentative of routine production.

The FDA strongly recommends a comprehensive assessment of operations