FDA Inspection 1210474 — Keystone Industries
The FDA completed an inspection of Keystone Industries on July 20, 2023 in Swedesboro, NJ. The inspection was classified VAI (Voluntary Action Indicated — objectionable conditions were found but do not meet the threshold for regulatory action). 3 citations were issued during this inspection. Product area: Drugs.
Inspection Details
- Classification
- Voluntary Action Indicated (VAI) (VAI)
- End Date
- July 20, 2023
- Fiscal Year
- 2023
- Product Type
- Drugs
- Project Area
- Drug Quality Assurance
- Location
- Swedesboro, NJ (United States)
Citations
| ID | CFR | Description |
|---|---|---|
| 1105 | 21 CFR 211.22(d) | Procedures not in writing, fully followed |
| 3629 | 21 CFR 211.170(b) | Reserve samples identified, representative, stored |
| 4399 | 21 CFR 211.186(b)(7) | Theoretical yield statement including percentages |