FDA Inspection 1100545 — Calmo Manufacturing, Inc
The FDA completed an inspection of Calmo Manufacturing, Inc on August 23, 2019 in Huntington Beach, 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
- August 23, 2019
- Fiscal Year
- 2019
- Product Type
- Drugs
- Project Area
- Drug Quality Assurance
- Location
- Huntington Beach, CA (United States)
Citations
| ID | CFR | Description |
|---|---|---|
| 1 | 21 CFR 11 | Electronic records |
| 1105 | 21 CFR 211.22(d) | Procedures not in writing, fully followed |
| 1177 | 21 CFR 211.63 | Equipment Design, Size and Location |
| 1810 | 21 CFR 211.160(a) | Lab controls established, including changes |