FDA Inspection 1153303 — Pyramid Laboratories, Inc.
The FDA completed an inspection of Pyramid Laboratories, Inc. on September 29, 2021 in Costa Mesa, CA. The inspection was classified VAI (Voluntary Action Indicated — objectionable conditions were found but do not meet the threshold for regulatory action). 5 citations were issued during this inspection. Product area: Drugs.
Inspection Details
- Classification
- Voluntary Action Indicated (VAI) (VAI)
- End Date
- September 29, 2021
- Fiscal Year
- 2021
- Product Type
- Drugs
- Project Area
- Drug Quality Assurance
- Location
- Costa Mesa, CA (United States)
Citations
| ID | CFR | Description |
|---|---|---|
| 1263 | 21 CFR 211.68(b) | Computer control of master formula records |
| 1434 | 21 CFR 211.42(c)(10)(iv) | Environmental Monitoring System |
| 1810 | 21 CFR 211.160(a) | Lab controls established, including changes |
| 2034 | 21 CFR 211.194(d) | Laboratory equipment calibration records |
| 3609 | 21 CFR 211.160(b)(2) | In-process sample representation/identification |