FDA Inspection 860321 — E P Evans Drugs Inc
The FDA completed an inspection of E P Evans Drugs Inc on Dec 16, 2013 in El Dorado Springs, MO. 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). 6 citations were issued during this inspection. Product area: Drugs.
Inspection Details
- Classification
- Voluntary Action Indicated (VAI)
- End Date
- Dec 16, 2013
- Fiscal Year
- 2014
- Product Type
- Drugs
- Project Area
- Drug Quality Assurance
- Location
- El Dorado Springs, MO (United States)
Citations
| ID | CFR | Description |
|---|---|---|
| 1261 | 21 CFR 211.68(a) | Written calibration / inspection records not kept |
| 1550 | 21 CFR 211.125(f) | Procedures Written and Followed |
| 1767 | 21 CFR 211.137(a) | Expiration date lacking |
| 1787 | 21 CFR 211.80(a) | Procedures To Be in Writing |
| 1798 | 21 CFR 211.82(b) | Quarantine Storage of Components |
| 1833 | 21 CFR 211.84(d)(1) | Identity Testing of Each Component |