FDA Inspection 978034 — Tom's Of Maine, Inc.
The FDA completed an inspection of Tom's Of Maine, Inc. on Jun 17, 2016 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). 4 citations were issued during this inspection. Product area: Drugs.
Inspection Details
- Classification
- Voluntary Action Indicated (VAI)
- End Date
- Jun 17, 2016
- Fiscal Year
- 2016
- Product Type
- Drugs
- Project Area
- Drug Quality Assurance
- Location
- Sanford, ME (United States)
Citations
| ID | CFR | Description |
|---|---|---|
| 1112 | 21 CFR 211.25(a) | Training--operations, GMPs, written procedures |
| 1450 | 21 CFR 211.113(a) | Procedures for non-sterile drug products |
| 3559 | 21 CFR 211.56(a) | Sanitation--buildings not clean, free of infestation |
| 4351 | 21 CFR 211.160(b)(3) | Drug products - samples representative, identified properly |