FDA Inspection 681349 — Grace Analytical Lab Inc
The FDA completed an inspection of Grace Analytical Lab Inc on September 23, 2010 in Berkeley, IL. The inspection was classified VAI (Voluntary Action Indicated — objectionable conditions were found but do not meet the threshold for regulatory action). 2 citations were issued during this inspection. Product area: Drugs.
Inspection Details
- Classification
- Voluntary Action Indicated (VAI) (VAI)
- End Date
- September 23, 2010
- Fiscal Year
- 2010
- Product Type
- Drugs
- Project Area
- Drug Quality Assurance
- Location
- Berkeley, IL (United States)
Citations
| ID | CFR | Description |
|---|---|---|
| 1133 | 21 CFR 211.25(a) | GMP Training Frequency |
| 3603 | 21 CFR 211.160(b) | Scientifically sound laboratory controls |