FDA Inspection
Southwood Pharmaceuticals IncSouthwood Pharmaceuticals Inc – FDA Inspection, Oct 11, 2011
Record Details
This FDA Inspection record concerns Southwood Pharmaceuticals Inc, with an inspection on October 11, 2011, issued by the Center for Drug Evaluation and Research, covering drugs.
- Inspection Date
- October 11, 2011
- Product Type
- Drugs
View Company Profile
ID · 63f019b4-cf85-4ce1-990c-63e1389b2251
Inspection Facts
Voluntary Action Indicated (VAI)
Objectionable conditions were found, but FDA is not prepared to take or recommend regulatory action.
- Inspection number
- 748446
- FDA center
- Human Drugs
- Project area
- Drug Quality Assurance
FDA Citations
6- 21 CFR 211.25(a)GMP Training Frequency
- 21 CFR 211.198(a)Procedures to be written and followed
- 21 CFR 211.68(a)Calibration/Inspection/Checking not done
- 21 CFR 211.42(c)Defined areas of adequate size for operations
- 21 CFR 211.180(e)(1)Review of representative number of batches
- 21 CFR 211.100(b)SOPs not followed / documented
Full citation text and observation details available on the Dashboard.
Other FDA inspections of Southwood Pharmaceuticals Inc
1| Date | Classification | Office | Project area |
|---|---|---|---|
| August 26, 2010 | VAI | Center for Drug Evaluation and Research | Drug Quality Assurance |
Other documents for Southwood Pharmaceuticals Inc
Document or profile
One record shows the event. A profile shows the pattern.
Buy this document for the source file and details behind this single event.
Choose full profile access to connect related records, sites, people, citations, and enforcement history in one view.