FDA Inspection
Old 97 CompanyOld 97 Company – FDA Inspection, Dec 27, 2012
Record Details
This FDA Inspection record concerns Old 97 Company, with an inspection on December 27, 2012, issued by the Center for Drug Evaluation and Research, covering drugs.
- Company
- Old 97 Company
- Inspection Date
- December 27, 2012
- Product Type
- Drugs
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ID · a9d58939-2ac9-495a-9ce2-9c20f77bd09d
Inspection Facts
Voluntary Action Indicated (VAI)
Objectionable conditions were found, but FDA is not prepared to take or recommend regulatory action.
- Inspection number
- 811630
- FDA center
- Human Drugs
- Project area
- Drug Quality Assurance
FDA Citations
15- 21 CFR 211.188(b)(9)Description of containers and closures
- 21 CFR 211.188(b)(10)Records of any sampling performed
- 21 CFR 211.188(b)(8)Labeling control records including specimens or copies
- 21 CFR 211.188(b)(1)Dates not included for each significant step
- 21 CFR 211.188(b)(6)Inspection of packaging and labeling area
- 21 CFR 211.186(b)(8)Description of containers, labels, et. al.
- 21 CFR 211.186(b)(7)Theoretical yield statement including percentages
- 21 CFR 211.84(d)(2)Reports of Analysis (Components)
- 21 CFR 211.165(a)Testing and release for distribution
- 21 CFR 211.188(b)(2)Identification of Equipment and Lines
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Other FDA inspections of Old 97 Company
1| Date | Classification | Office | Project area |
|---|---|---|---|
| October 21, 2009 | VAI | Center for Drug Evaluation and Research | Drug Quality Assurance |
Other documents for Old 97 Company
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