FDA Inspection 1134475 — Infinity Laboratories LLC
The FDA completed an inspection of Infinity Laboratories LLC on January 7, 2021 in Castle Rock, CO. 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
- January 7, 2021
- Fiscal Year
- 2021
- Product Type
- Drugs
- Project Area
- Drug Quality Assurance
- Location
- Castle Rock, CO (United States)
Citations
| ID | CFR | Description |
|---|---|---|
| 2031 | 21 CFR 211.194(a) | Complete test data included in records |
| 3607 | 21 CFR 211.160(b)(2) | Acceptance of in-process materials |
| 4352 | 21 CFR 211.160(b)(4) | Calibration - at intervals, written program, remedial action |
| 4402 | 21 CFR 211.192 | Written record of investigation incomplete |