FDA Inspection 1147163 — ProFresh International Corp.
The FDA completed an inspection of ProFresh International Corp. on July 16, 2021 in Philadelphia, PA. The inspection was classified OAI (Official Action Indicated — objectionable conditions were found and regulatory action is recommended). 3 citations were issued during this inspection. Product area: Drugs.
Inspection Details
- Classification
- Official Action Indicated (OAI) (OAI)
- End Date
- July 16, 2021
- Fiscal Year
- 2021
- Product Type
- Drugs
- Project Area
- Drug Quality Assurance
- Location
- Philadelphia, PA (United States)
Citations
| ID | CFR | Description |
|---|---|---|
| 1105 | 21 CFR 211.22(d) | Procedures not in writing, fully followed |
| 1134 | 21 CFR 211.25(b) | Supervisor Training/Education/Experience |
| 4389 | 21 CFR 211.198(a) | Procedures to be written and followed |