FDA Inspection 1156779 — The Belport Company, Inc
The FDA completed an inspection of The Belport Company, Inc on Nov 12, 2021 in Camarillo, CA. The inspection was classified VAI (Voluntary Action Indicated — objectionable conditions or practices were found, but the agency is not prepared to take or recommend any administrative or regulatory action). 7 citations were issued during this inspection. Product area: Drugs.
Inspection details
- Classification
- Voluntary Action Indicated (VAI)
- End Date
- Nov 12, 2021
- Fiscal Year
- 2022
- Product Type
- Drugs
- Project Area
- Drug Quality Assurance
- Location
- Camarillo, CA (United States)
Citations
| ID | CFR | Description |
|---|---|---|
| 1215 | 21 CFR 211.67(b) | Written procedures not established/followed |
| 1358 | 21 CFR 211.100(b) | SOPs not followed / documented |
| 1450 | 21 CFR 211.113(a) | Procedures for non-sterile drug products |
| 1914 | 21 CFR 211.166(a) | Lack of written stability program |
| 2007 | 21 CFR 211.186(a) | Signature and checking of records -- 2 persons |
| 4330 | 21 CFR 211.130(e) | Packaging line inspection documentation |
| 4402 | 21 CFR 211.192 | Written record of investigation incomplete |