FDA Inspection
Southwood Pharmaceuticals IncSouthwood Pharmaceuticals Inc – FDA Inspection, Aug 26, 2010
Record Details
This FDA Inspection record concerns Southwood Pharmaceuticals Inc, with an inspection on August 26, 2010, issued by the Center for Drug Evaluation and Research, covering drugs.
- Inspection Date
- August 26, 2010
- Product Type
- Drugs
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ID · 3600733a-e418-4c5f-989b-5c09504e1407
Inspection Facts
Voluntary Action Indicated (VAI)
Objectionable conditions were found, but FDA is not prepared to take or recommend regulatory action.
- Inspection number
- 677462
- FDA center
- Human Drugs
- Project area
- Drug Quality Assurance
FDA Citations
7- 21 CFR 211.84(c)(6)Containers Marked to Show Samples Taken
- 21 CFR 211.25(a)Training--operations, GMPs, written procedures
- 21 CFR 211.46(b)Equipment for Environmental Control
- 21 CFR 211.25(a)GMP Training Frequency
- 21 CFR 211.68(a)Calibration/Inspection/Checking not done
- 21 CFR 211.42(d)Penicillin processing area not kept separate
- 21 CFR 211.182Personnel dating/signing equipment log
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Other FDA inspections of Southwood Pharmaceuticals Inc
1| Date | Classification | Office | Project area |
|---|---|---|---|
| October 11, 2011 | VAI | Center for Drug Evaluation and Research | Drug Quality Assurance |
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