FDA Inspection
Tufco, L.P.Tufco, L.P. – FDA Inspection, Nov 1, 2011
Record Details
This FDA Inspection record concerns Tufco, L.P., with an inspection on November 1, 2011, issued by the Center for Drug Evaluation and Research, covering drugs.
- Company
- Tufco, L.P.
- Inspection Date
- November 1, 2011
- Product Type
- Drugs
View Company Profile
ID · 6518dfcc-6864-4f9a-a29b-657f8a40a9dd
Inspection Facts
Voluntary Action Indicated (VAI)
Objectionable conditions were found, but FDA is not prepared to take or recommend regulatory action.
- Inspection number
- 754965
- FDA center
- Human Drugs
- Project area
- Drug Quality Assurance
FDA Citations
3- 21 CFR 211.166(a)Lack of written stability program
- 21 CFR 211.180(e)(1)Review of representative number of batches
- 21 CFR 211.67(b)Written procedures fail to include
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Other FDA inspections of Tufco, L.P.
1| Date | Classification | Office | Project area |
|---|---|---|---|
| May 13, 2015 | VAI | Center for Drug Evaluation and Research | Drug Quality Assurance |
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