FDA Inspection
GDMI, IncGDMI, Inc – FDA Inspection, Jun 29, 2009
Record Details
This FDA Inspection record concerns GDMI, Inc, with an inspection on June 29, 2009, issued by the Center for Drug Evaluation and Research, covering drugs.
- Company
- GDMI, Inc
- Inspection Date
- June 29, 2009
- Product Type
- Drugs
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ID · 5b60de57-2dca-4ab5-8ce9-06b3ab8487c8
Inspection Facts
Official Action Indicated (OAI)
Significant objectionable conditions were found and regulatory or administrative action is recommended.
- Inspection number
- 595774
- FDA center
- Human Drugs
- Project area
- Drug Quality Assurance
FDA Citations
17- 21 CFR 211.188Prepared for each batch, include complete information
- 21 CFR 211.56(a)Sanitation--buildings not clean, free of infestation
- 21 CFR 211.100(a)Changes to Procedures Not Reviewed, Approved
- 21 CFR 211.25(a)Training , Education , Experience overall
- 21 CFR 211.67(a)Cleaning / Sanitizing / Maintenance
- 21 CFR 211.192Extent of discrepancy, failure investigations
- 21 CFR 211.160(b)(1)Incoming lots - conformance to written specs-
- 21 CFR 211.194(c)Testing and standardization of standards et. al.
- 21 CFR 211.204Associated batches implicated, investigated
- 21 CFR 211.198(a)Procedures to be written and followed
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Other FDA inspections of GDMI, Inc
2| Date | Classification | Office | Project area |
|---|---|---|---|
| July 25, 2018 | NAI | Center for Veterinary Medicine | Monitoring of Marketed Animal Drugs, Feed, and Devices |
| December 15, 2010 | VAI | Center for Food Safety and Applied Nutrition | Colors and Cosmetics Technology |
Other documents for GDMI, Inc
- FDA Inspection 1060756 - 2018-07-25
- FDA Inspection 702884 - 2010-12-15
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