FDA Inspection 1010372 — Tedor Pharma, Inc.
The FDA completed an inspection of Tedor Pharma, Inc. on Apr 20, 2017 in Cumberland, RI. 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). 4 citations were issued during this inspection. Product area: Drugs.
Inspection Details
- Classification
- Voluntary Action Indicated (VAI)
- End Date
- Apr 20, 2017
- Fiscal Year
- 2017
- Product Type
- Drugs
- Project Area
- Drug Quality Assurance
- Location
- Cumberland, RI (United States)
Citations
| ID | CFR | Description |
|---|---|---|
| 1450 | 21 CFR 211.113(a) | Procedures for non-sterile drug products |
| 2028 | 21 CFR 211.192 | Extent of discrepancy, failure investigations |
| 2205 | 21 CFR 211.186(b)(9) | Manufacturing Instructions and Specifications |
| 4391 | 21 CFR 211.180(e)(2) | Items to cover on annual reviews |