FDA Inspection 983399 — Apex360, LLC
The FDA completed an inspection of Apex360, LLC on July 7, 2016 in Burlington, KY. The inspection was classified VAI (Voluntary Action Indicated — objectionable conditions were found but do not meet the threshold for regulatory action). 4 citations were issued during this inspection. Product area: Drugs.
Inspection Details
- Classification
- Voluntary Action Indicated (VAI) (VAI)
- End Date
- July 7, 2016
- Fiscal Year
- 2016
- Product Type
- Drugs
- Project Area
- Drug Quality Assurance
- Location
- Burlington, KY (United States)
Citations
| ID | CFR | Description |
|---|---|---|
| 1112 | 21 CFR 211.25(a) | Training--operations, GMPs, written procedures |
| 1361 | 21 CFR 211.100(a) | Absence of Written Procedures |
| 1626 | 21 CFR 211.130 | Procedures are written, and followed |
| 4328 | 21 CFR 211.122(a) | Written procedures not followed |