GDMI, Inc – FDA Warning Letter, Jun 29, 2009

On June 11-29, 2009, an FDA inspection of GDMI, Inc. in Garland, Texas, revealed significant Current Good Manufacturing Practice (CGMP) violations for Finished Pharmaceuticals, rendering drug products adulterated. Additionally, several Over-the-Counter (OTC) drug products were identified as unapproved "new drugs" and/or misbranded.

Key violations include: 1. **Component Testing:** Failure to perform identity testing on all components (e.g., epinephrine, hydrocortisone) and validate supplier analyses, relying solely on Certificates of Analysis. 2. **Equipment Cleaning:** Inadequate written procedures and validation for equipment cleaning, with observed residue on "cleaned" equipment. 3. **Record Keeping:** Failure to maintain proper records for equipment cleaning and maintenance, including product identification. 4. **Microbial Control:** Lack of validation for the purified water system and absence of preservative effectiveness testing for finished products. 5. **Quality Control Unit:** Absence of an established, independent quality control unit with authority to approve/reject materials and investigate failures. 6. **Investigation of Discrepancies:** Failure to thoroughly investigate out-of-specification (OOS) results for drug product batches. 7. **Production and Process Control:** Lack of validated manufacturing processes and a written change control procedure. 8. **Stability Testing:** Non-adherence to written stability testing procedures for drug products. 9. **Employee Training