FDA Inspection 582249 — ProCore Pharma, LLC
The FDA completed an inspection of ProCore Pharma, LLC on May 4, 2009 in Coppell, TX. The inspection was classified VAI (Voluntary Action Indicated — objectionable conditions were found but do not meet the threshold for regulatory action). 7 citations were issued during this inspection. Product area: Food/Cosmetics.
Inspection Details
- Classification
- Voluntary Action Indicated (VAI) (VAI)
- End Date
- May 4, 2009
- Fiscal Year
- 2009
- Product Type
- Food/Cosmetics
- Project Area
- Colors and Cosmetics Technology
- Location
- Coppell, TX (United States)
Citations
| ID | CFR | Description |
|---|---|---|
| 1112 | 21 CFR 211.25(a) | Training--operations, GMPs, written procedures |
| 1215 | 21 CFR 211.67(b) | Written procedures not established/followed |
| 1361 | 21 CFR 211.100(a) | Absence of Written Procedures |
| 1454 | 21 CFR 211.115(a) | Reprocessing procedures not written or followed |
| 1767 | 21 CFR 211.137(a) | Expiration date lacking |
| 1798 | 21 CFR 211.82(b) | Quarantine Storage of Components |
| 1914 | 21 CFR 211.166(a) | Lack of written stability program |