FDA WARNING_LETTER - Fagron Compounding Services - June 28, 2024

On December 19, 2024, the FDA issued Warning Letter #698861 to Fagron Compounding Services, LLC dba Fagron Sterile Services, an outsourcing facility registered under section 503B of the FDCA. The letter followed an inspection from June 18-28, 2024, which revealed serious deficiencies in sterile drug production and non-compliance with 503B conditions.

Violations included drug products failing to meet 503B labeling requirements, such as missing dosage form, established drug name, and active ingredient lists on product and container labels. These failures render the products ineligible for exemptions from FDA approval, adequate directions for use, and Drug Supply Chain Security Act requirements.

Furthermore, the FDA found adulterated drug products due to insanitary conditions and CGMP violations. Specific issues included inadequate product evaluation after microbial contamination in the ISO 5 aseptic area, production during construction without contamination controls, failure to investigate discrepancies (21 CFR 211.192), poor facility maintenance (21 CFR 211.56(a)), and lack of validated aseptic and sterilization procedures (21 CFR 211.113(b)).

The firm's drug products are considered unapproved new drugs and misbranded because they lack FDA approval and adequate directions for use for conditions not amenable to self-diagnosis.

While the FDA acknowledged the firm