FDA Inspection 963304 — Time-Cap Laboratories, Inc.
The FDA completed an inspection of Time-Cap Laboratories, Inc. on March 10, 2016 in Farmingdale, NY. The inspection was classified VAI (Voluntary Action Indicated — objectionable conditions were found but do not meet the threshold for regulatory action). 2 citations were issued during this inspection. Product area: Drugs.
Inspection Details
- Classification
- Voluntary Action Indicated (VAI) (VAI)
- End Date
- March 10, 2016
- Fiscal Year
- 2016
- Product Type
- Drugs
- Project Area
- Drug Quality Assurance
- Location
- Farmingdale, NY (United States)
Citations
| ID | CFR | Description |
|---|---|---|
| 1133 | 21 CFR 211.25(a) | GMP Training Frequency |
| 1922 | 21 CFR 211.166(a)(4) | Testing in same container - closure system |