FDA Inspection 945269 — Zep Inc
The FDA completed an inspection of Zep Inc on July 23, 2015 in Emerson, GA. The inspection was classified VAI (Voluntary Action Indicated — objectionable conditions were found but do not meet the threshold for regulatory action). 9 citations were issued during this inspection. Product area: Drugs.
Inspection Details
- Classification
- Voluntary Action Indicated (VAI) (VAI)
- End Date
- July 23, 2015
- Fiscal Year
- 2015
- Product Type
- Drugs
- Project Area
- Drug Quality Assurance
- Location
- Emerson, GA (United States)
Citations
| ID | CFR | Description |
|---|---|---|
| 1495 | 21 CFR 211.122(a) | Written procedures describing in detail |
| 1505 | 21 CFR 211.122(d) | Label storage access limited to authorized personnel |
| 1774 | 21 CFR 211.142(a) | Quarantine - actual practice |
| 1798 | 21 CFR 211.82(b) | Quarantine Storage of Components |
| 1922 | 21 CFR 211.166(a)(4) | Testing in same container - closure system |
| 3562 | 21 CFR 211.56(c) | Written procedures lacking for use of pesticides etc. |
| 3630 | 21 CFR 211.170(b) | Drug product reserve containers |
| 4340 | 21 CFR 211.142 | Written warehousing procedures established/followed |
| 4352 | 21 CFR 211.160(b)(4) | Calibration - at intervals, written program, remedial action |