FDA Inspection 1031525 — Safetec Of America, Inc.
The FDA completed an inspection of Safetec Of America, Inc. on November 17, 2017 in Buffalo, NY. The inspection was classified VAI (Voluntary Action Indicated — objectionable conditions were found but do not meet the threshold for regulatory action). 4 citations were issued during this inspection. Product area: Drugs.
Inspection Details
- Classification
- Voluntary Action Indicated (VAI) (VAI)
- End Date
- November 17, 2017
- Fiscal Year
- 2018
- Product Type
- Drugs
- Project Area
- Drug Quality Assurance
- Location
- Buffalo, NY (United States)
Citations
| ID | CFR | Description |
|---|---|---|
| 1926 | 21 CFR 211.166(b) | Adequate number of batches on stability |
| 3612 | 21 CFR 211.160(b)(3) | Sampling/testing of drug products |
| 4315 | 21 CFR 211.84(d)(2) | Testing Each Component for Conformity with Specs |
| 4406 | 21 CFR 211.194(a)(2) | Suitability of testing methods verified |