FDA Inspection 831973 — Elanco UK AH Limited
The FDA completed an inspection of Elanco UK AH Limited on May 9, 2013 in Speke, Liverpool. The inspection was classified VAI (Voluntary Action Indicated — objectionable conditions were found but do not meet the threshold for regulatory action). 4 citations were issued during this inspection. Product area: Drugs.
Inspection Details
- Classification
- Voluntary Action Indicated (VAI) (VAI)
- End Date
- May 9, 2013
- Fiscal Year
- 2013
- Product Type
- Drugs
- Project Area
- Drug Quality Assurance
- Location
- Speke, Liverpool (United Kingdom)
Citations
| ID | CFR | Description |
|---|---|---|
| 1105 | 21 CFR 211.22(d) | Procedures not in writing, fully followed |
| 1920 | 21 CFR 211.166(a)(3) | Valid stability test methods |
| 3559 | 21 CFR 211.56(a) | Sanitation--buildings not clean, free of infestation |
| 3603 | 21 CFR 211.160(b) | Scientifically sound laboratory controls |