FDA Inspection 1229332 — PediFix, Inc.
The FDA completed an inspection of PediFix, Inc. on Feb 12, 2024 in Brewster, NY. 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). 3 citations were issued during this inspection. Product area: Drugs.
Inspection Details
- Classification
- Voluntary Action Indicated (VAI)
- End Date
- Feb 12, 2024
- Fiscal Year
- 2024
- Product Type
- Drugs
- Project Area
- Drug Quality Assurance
- Location
- Brewster, NY (United States)
Citations
| ID | CFR | Description |
|---|---|---|
| 1079 | 21 CFR 211.22(a) | Contract drug products--lack of responsibility |
| 1263 | 21 CFR 211.68(b) | Computer control of master formula records |
| 3632 | 21 CFR 211.170(b) | Annual visual exams of drug products |