FDA Inspection 746047 — Gulf Coast Pharmaceutical Specialty
The FDA completed an inspection of Gulf Coast Pharmaceutical Specialty on Sep 21, 2011 in Gonzales, LA. The inspection was classified VAI (Voluntary Action Indicated — objectionable conditions or practices were found, but the agency is not prepared to take or recommend any administrative or regulatory action). 5 citations were issued during this inspection. Product area: Drugs.
Inspection Details
- Classification
- Voluntary Action Indicated (VAI)
- End Date
- Sep 21, 2011
- Fiscal Year
- 2011
- Product Type
- Drugs
- Project Area
- Drug Quality Assurance
- Location
- Gonzales, LA (United States)
Citations
| ID | CFR | Description |
|---|---|---|
| 1112 | 21 CFR 211.25(a) | Training--operations, GMPs, written procedures |
| 1361 | 21 CFR 211.100(a) | Absence of Written Procedures |
| 1540 | 21 CFR 211.125(a) | Strict control not exercised over labeling issued |
| 1868 | 21 CFR 211.94(b) | Protection from external factors |
| 9001 | 21 CFR 211.22(a) | Lack of quality control unit |