FDA Inspection 578187 — Tom's Of Maine, Inc.
The FDA completed an inspection of Tom's Of Maine, Inc. on Apr 10, 2009 in Sanford, ME. 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
- Apr 10, 2009
- Fiscal Year
- 2009
- Product Type
- Drugs
- Project Area
- Drug Quality Assurance
- Location
- Sanford, ME (United States)
Citations
| ID | CFR | Description |
|---|---|---|
| 1976 | 21 CFR 211.182 | Specific information required in individual logs |
| 4366 | 21 CFR 211.188(a) | Accurate reproduction included |
| 4377 | 21 CFR 211.188(b)(3) | Identification of each component or in-process material |
| 4382 | 21 CFR 211.198(b)(2) | Written record of complaint to include findings, follow-up |
| 4417 | 21 CFR 211.204 | Associated batches implicated, investigated |