FDA Inspection 675357 — Elementis SRL, Inc.
The FDA completed an inspection of Elementis SRL, Inc. on Jul 9, 2010 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). 3 citations were issued during this inspection. Product area: Drugs.
Inspection Details
- Classification
- Voluntary Action Indicated (VAI)
- End Date
- Jul 9, 2010
- Fiscal Year
- 2010
- Product Type
- Drugs
- Project Area
- Drug Quality Assurance
- Location
- Middletown, NY (United States)
Citations
| ID | CFR | Description |
|---|---|---|
| 1111 | 21 CFR 211.25(a) | Training , Education , Experience overall |
| 3594 | 21 CFR 211.110(d) | Rejected in-process materials not quarantined |
| 4352 | 21 CFR 211.160(b)(4) | Calibration - at intervals, written program, remedial action |