FDA Inspection 808984 — Beaumont Products Inc.
The FDA completed an inspection of Beaumont Products Inc. on November 6, 2012 in Kennesaw, GA. The inspection was classified VAI (Voluntary Action Indicated — objectionable conditions were found but do not meet the threshold for regulatory action). 12 citations were issued during this inspection. Product area: Drugs.
Inspection Details
- Classification
- Voluntary Action Indicated (VAI) (VAI)
- End Date
- November 6, 2012
- Fiscal Year
- 2013
- Product Type
- Drugs
- Project Area
- Drug Quality Assurance
- Location
- Kennesaw, GA (United States)
Citations
| ID | CFR | Description |
|---|---|---|
| 1105 | 21 CFR 211.22(d) | Procedures not in writing, fully followed |
| 1133 | 21 CFR 211.25(a) | GMP Training Frequency |
| 1136 | 21 CFR 211.25(c) | Inadequate number of personnel |
| 1393 | 21 CFR 211.103 | Yield calculations not verified by 2nd person |
| 1978 | 21 CFR 211.182 | Personnel dating/signing equipment log |
| 3547 | 21 CFR 211.46(b) | Equipment for Environmental Control |
| 3565 | 21 CFR 211.58 | Buildings not maintained in good state of repair |
| 3585 | 21 CFR 211.110(a) | Control procedures to monitor and validate performance |
| 3632 | 21 CFR 211.170(b) | Annual visual exams of drug products |
| 4303 | 21 CFR 211.67(b) | Written procedures fail to include |
| 4391 | 21 CFR 211.180(e)(2) | Items to cover on annual reviews |
| 4402 | 21 CFR 211.192 | Written record of investigation incomplete |