FDA Inspection 1271216 — Wells Pharmacy, Inc
The FDA completed an inspection of Wells Pharmacy, Inc on Apr 25, 2025 in Dyersburg, TN. 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
- Apr 25, 2025
- Fiscal Year
- 2025
- Product Type
- Drugs
- Project Area
- Drug Quality Assurance
- Location
- Dyersburg, TN (United States)
Citations
| ID | CFR | Description |
|---|---|---|
| 1868 | 21 CFR 211.94(b) | Protection from external factors |
| 1938 | 21 CFR 211.167(c) | Controlled release dosage form testing |
| 22787 | FDCA 503B(a)(10)(A) | Drug product labels, fails to include |
| 3603 | 21 CFR 211.160(b) | Scientifically sound laboratory controls |