FDA Inspection 889635 — Eurofins Lancaster Laboratories, Inc
The FDA completed an inspection of Eurofins Lancaster Laboratories, Inc on Aug 1, 2014 in Portage, MI. 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
- Aug 1, 2014
- Fiscal Year
- 2014
- Product Type
- Drugs
- Project Area
- Drug Quality Assurance
- Location
- Portage, MI (United States)
Citations
| ID | CFR | Description |
|---|---|---|
| 1270 | 21 CFR 211.68(b) | input/output verification |
| 1917 | 21 CFR 211.166(a)(1) | Sample size - test intervals |
| 3603 | 21 CFR 211.160(b) | Scientifically sound laboratory controls |