866677
PI Pharma Inc — FEI 3006481857
Inspection Details
- Classification
- Official Action Indicated (OAI) (OAI)
- End Date
- February 19, 2014
- Fiscal Year
- 2014
- Product Type
- Drugs
- Project Area
- Unapproved and Misbranded Drugs
- Location
- Campton, KY (United States)
Citations
| ID | CFR | Description |
|---|
| 1213 | 21 CFR 211.67(a) | Cleaning / Sanitizing / Maintenance |
| 1361 | 21 CFR 211.100(a) | Absence of Written Procedures |
| 15505 | 21 CFR 111.27(a)(3)(v) | Equipment - protect from contamination |
| 15665 | 21 CFR 111.303 | Written procedures - tests, examinations; specifications met |
| 15832 | 21 CFR 111.70(c)(1) | In-process identity, purity, strength, composition |
| 15858 | 21 CFR 111.75(a)(1)(i) | Component - verify identity, dietary ingredient |
| 1767 | 21 CFR 211.137(a) | Expiration date lacking |
| 1883 | 21 CFR 211.165(a) | Testing and release for distribution |
| 4314 | 21 CFR 211.84(d)(2) | Reports of Analysis (Components) |