FDA Inspection
Old 97 CompanyOld 97 Company – FDA Inspection, Oct 21, 2009
Record Details
This FDA Inspection record concerns Old 97 Company, with an inspection on October 21, 2009, issued by the Center for Drug Evaluation and Research, covering drugs.
- Company
- Old 97 Company
- Inspection Date
- October 21, 2009
- Product Type
- Drugs
View Company Profile
ID · af48b419-dc64-445f-9978-355bd641d61a
Inspection Facts
Voluntary Action Indicated (VAI)
Objectionable conditions were found, but FDA is not prepared to take or recommend regulatory action.
- Inspection number
- 621396
- FDA center
- Human Drugs
- Project area
- Drug Quality Assurance
FDA Citations
7- 21 CFR 211.188Prepared for each batch, include complete information
- 21 CFR 211.160(b)Scientifically sound laboratory controls
- 21 CFR 211.166(a)Lack of written stability program
- 21 CFR 211.180(e)(2)Items to cover on annual reviews
- 21 CFR 211.100(b)SOPs not followed / documented
- 21 CFR 211.192No written record of investigation
- 21 CFR 211.182Written records kept in individual logs
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Other FDA inspections of Old 97 Company
1| Date | Classification | Office | Project area |
|---|---|---|---|
| December 27, 2012 | VAI | Center for Drug Evaluation and Research | Drug Quality Assurance |
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