FDA Inspection 1005499 — Forma Life Sciences, Inc
The FDA completed an inspection of Forma Life Sciences, Inc on March 3, 2017 in Irvine, CA. 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
- March 3, 2017
- Fiscal Year
- 2017
- Product Type
- Drugs
- Project Area
- Drug Quality Assurance
- Location
- Irvine, CA (United States)
Citations
| ID | CFR | Description |
|---|---|---|
| 1263 | 21 CFR 211.68(b) | Computer control of master formula records |
| 2027 | 21 CFR 211.192 | Investigations of discrepancies, failures |
| 3603 | 21 CFR 211.160(b) | Scientifically sound laboratory controls |
| 4340 | 21 CFR 211.142 | Written warehousing procedures established/followed |