FDA Inspection
The Dodge Company, Inc.The Dodge Company, Inc. – FDA Inspection, Jul 2, 2009
Record Details
This FDA Inspection record concerns The Dodge Company, Inc., with an inspection on July 2, 2009, issued by the Center for Drug Evaluation and Research, covering drugs.
- Company
- The Dodge Company, Inc.
- Inspection Date
- July 2, 2009
- Product Type
- Drugs
View Company Profile
ID · 8ab7574e-6bff-45b8-93e0-dd8a278e684f
Inspection Facts
Voluntary Action Indicated (VAI)
Objectionable conditions were found, but FDA is not prepared to take or recommend regulatory action.
- Inspection number
- 596071
- FDA center
- Human Drugs
- Project area
- Drug Quality Assurance
FDA Citations
9- 21 CFR 211.56(a)Sanitation--buildings not clean, free of infestation
- 21 CFR 211.192Quality control unit review of records
- 21 CFR 211.67(a)Cleaning / Sanitizing / Maintenance
- 21 CFR 211.25(a)GMP Training Frequency
- 21 CFR 211.67(c)Cleaning/maintenance records not kept
- 21 CFR 211.22(d)Procedures not in writing, fully followed
- 21 CFR 211.80(b)Handling and Storage to Prevent Contamination
- 21 CFR 211.166(a)Written program not followed
- 21 CFR 211.180(e)(2)Items to cover on annual reviews
Full citation text and observation details available on the Dashboard.
Other FDA inspections of The Dodge Company, Inc.
1| Date | Classification | Office | Project area |
|---|---|---|---|
| March 25, 2014 | VAI | Center for Drug Evaluation and Research | Drug Quality Assurance |
Other documents for The Dodge Company, Inc.
- FDA Inspection 870456 - 2014-03-25
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