FDA Inspection 1039775 — The Original Bradford Soap Works, Inc.
The FDA completed an inspection of The Original Bradford Soap Works, Inc. on Feb 2, 2018 in West Warwick, RI. 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). 5 citations were issued during this inspection. Product area: Drugs.
Inspection Details
- Classification
- Voluntary Action Indicated (VAI)
- End Date
- Feb 2, 2018
- Fiscal Year
- 2018
- Product Type
- Drugs
- Project Area
- Drug Quality Assurance
- Location
- West Warwick, RI (United States)
Citations
| ID | CFR | Description |
|---|---|---|
| 1219 | 21 CFR 211.67(b)(2) | Cleaning SOPs/schedules |
| 1263 | 21 CFR 211.68(b) | Computer control of master formula records |
| 1917 | 21 CFR 211.166(a)(1) | Sample size - test intervals |
| 1942 | 21 CFR 211.180(e) | Records reviewed annually |
| 4323 | 21 CFR 211.115(a) | Reprocessing procedures lack steps to be taken |