FDA Inspection 656096 — Phoenix Divina Products Llc
The FDA completed an inspection of Phoenix Divina Products Llc on Apr 7, 2010 in Terryville, CT. 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). 10 citations were issued during this inspection. Product area: Drugs.
Inspection Details
- Classification
- Voluntary Action Indicated (VAI)
- End Date
- Apr 7, 2010
- Fiscal Year
- 2010
- Product Type
- Drugs
- Project Area
- Drug Quality Assurance
- Location
- Terryville, CT (United States)
Citations
| ID | CFR | Description |
|---|---|---|
| 1134 | 21 CFR 211.25(b) | Supervisor Training/Education/Experience |
| 1358 | 21 CFR 211.100(b) | SOPs not followed / documented |
| 1454 | 21 CFR 211.115(a) | Reprocessing procedures not written or followed |
| 1629 | 21 CFR 211.130(a) | Prevention of cross contamination, mix-ups |
| 1787 | 21 CFR 211.80(a) | Procedures To Be in Writing |
| 1883 | 21 CFR 211.165(a) | Testing and release for distribution |
| 1942 | 21 CFR 211.180(e) | Records reviewed annually |
| 2009 | 21 CFR 211.188 | Prepared for each batch, include complete information |
| 3570 | 21 CFR 211.100(a) | Approval and review of procedures |
| 4576 | 21 CFR 211.192 | No written record of investigation |