FDA Inspection 987936 — Elementis SRL, Inc.
The FDA completed an inspection of Elementis SRL, Inc. on Oct 5, 2016 in Middletown, NY. 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
- Oct 5, 2016
- Fiscal Year
- 2017
- Product Type
- Drugs
- Project Area
- Drug Quality Assurance
- Location
- Middletown, NY (United States)
Citations
| ID | CFR | Description |
|---|---|---|
| 1274 | 21 CFR 211.68(a) | Calibration/Inspection/Checking not done |
| 1842 | 21 CFR 211.84(d)(1) | Component identity verification |
| 1886 | 21 CFR 211.165(c) | Sampling and testing plans not described |
| 4340 | 21 CFR 211.142 | Written warehousing procedures established/followed |