# FDA WARNING_LETTER - GDMI, Inc - June 29, 2009

Source: https://www.keypedia.com/records/warning_letter/gdmi-inc/a0f98d3b-d544-4e31-94e7-fecb8ebddf11

> FDA WARNING_LETTER for GDMI, Inc on June 29, 2009. Product: Drugs. Access full analysis and detailed observations.

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## Details

- Record Type: WARNING_LETTER
- Company Name: GDMI, Inc
- Inspection Date: 2009-06-29
- Product Type: Drugs
- Office Name: Dallas District Office
- Summary: 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

## Related Officers

- [Terry Meacham](https://www.keypedia.com/people/terry-meacham/109c459a-db6d-45b0-82bf-2558b5312705)
- [District Director](https://www.keypedia.com/people/reynaldo-rodriguez/6e765ccb-f28d-433b-85cb-eafb8b8c35df)

Company: https://www.keypedia.com/companies/gdmi-inc/b08968ad-1345-4309-9390-ea37400c47d3

Office: https://www.keypedia.com/offices/dallas-district-office/2d1ee9ae-c44c-4494-8186-a920a69b98f9