FDA Inspection 1231469 — Tom's of Maine, Inc.
The FDA completed an inspection of Tom's of Maine, Inc. on May 22, 2024 in Sanford, ME. The inspection was classified OAI (Official Action Indicated — objectionable conditions were found and regulatory action is recommended). 4 citations were issued during this inspection. Product area: Drugs.
Inspection Details
- Classification
- Official Action Indicated (OAI) (OAI)
- End Date
- May 22, 2024
- Fiscal Year
- 2024
- Product Type
- Drugs
- Project Area
- Drug Quality Assurance
- Location
- Sanford, ME (United States)
Citations
| ID | CFR | Description |
|---|---|---|
| 1105 | 21 CFR 211.22(d) | Procedures not in writing, fully followed |
| 1450 | 21 CFR 211.113(a) | Procedures for non-sterile drug products |
| 2027 | 21 CFR 211.192 | Investigations of discrepancies, failures |
| 3565 | 21 CFR 211.58 | Buildings not maintained in good state of repair |