FDA Inspection 815981 — Keystone Industries
The FDA completed an inspection of Keystone Industries on Feb 6, 2013 in Gibbstown, NJ. 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). 5 citations were issued during this inspection. Product area: Drugs.
Inspection Details
- Classification
- Voluntary Action Indicated (VAI)
- End Date
- Feb 6, 2013
- Fiscal Year
- 2013
- Product Type
- Drugs
- Project Area
- Drug Quality Assurance
- Location
- Gibbstown, NJ (United States)
Citations
| ID | CFR | Description |
|---|---|---|
| 1134 | 21 CFR 211.25(b) | Supervisor Training/Education/Experience |
| 1448 | 21 CFR 211.111 | Establishment of time limitations |
| 1920 | 21 CFR 211.166(a)(3) | Valid stability test methods |
| 1926 | 21 CFR 211.166(b) | Adequate number of batches on stability |
| 4400 | 21 CFR 211.186(b)(8) | Description of containers, labels, et. al. |