FDA WARNING_LETTER - MedOffice Saglik Endustri Anonim Sirketi - May 10, 2024

On October 23, 2024, the FDA issued a Warning Letter to MedOffice Saglik Endustri Anonim Sirketi, FEI 3019167311, following an inspection from May 6 to 10, 2024, at their facility in Torbali, Izmir, Turkey. The letter details significant violations of Current Good Manufacturing Practice (CGMP) regulations for finished pharmaceuticals (21 CFR parts 210 and 211), rendering their drug products adulterated under section 501(a)(2)(B) of the FD&C Act.

The FDA found the firm's May 15, 2024, response to the Form FDA 483 inadequate due to insufficient supportive documentation and evidence of corrective actions. Key violations include:

1. **Failure to perform appropriate laboratory testing for drug product release (21 CFR 211.165(a) and 211.165(b)):** The firm failed to test OTC drug products, including identity and strength of active ingredients, and lacked adequate microbiological testing, even for products with microbial contamination complaints. Required actions include providing chemical and microbial specifications, an action plan for testing retain samples of all distributed batches within expiry, and a summary of results with corrective actions for substandard products.

2. **Failure to test incoming components and validate supplier