FDA Inspection 742077 — ProCore Pharma, LLC
The FDA completed an inspection of ProCore Pharma, LLC on September 8, 2011 in Coppell, TX. The inspection was classified OAI (Official Action Indicated — objectionable conditions were found and regulatory action is recommended). 13 citations were issued during this inspection. Product area: Food/Cosmetics.
Inspection Details
- Classification
- Official Action Indicated (OAI) (OAI)
- End Date
- September 8, 2011
- Fiscal Year
- 2011
- Product Type
- Food/Cosmetics
- Project Area
- Food Composition, Standards, Labeling and Econ
- Location
- Coppell, TX (United States)
Citations
| ID | CFR | Description |
|---|---|---|
| 1215 | 21 CFR 211.67(b) | Written procedures not established/followed |
| 1361 | 21 CFR 211.100(a) | Absence of Written Procedures |
| 1540 | 21 CFR 211.125(a) | Strict control not exercised over labeling issued |
| 15404 | 21 CFR 111.12(c) | Personnel - education, training, experience |
| 15566 | 21 CFR 111.260(l)(3) | Batch record - approved, released, rejected; batch |
| 15579 | 21 CFR 111.155(c)(1) | Components - representative samples |
| 15829 | 21 CFR 111.70(b)(1) | Specifications - component identity |
| 15839 | 21 CFR 111.70(e) | Specifications - identity, purity, strength, composition |
| 15861 | 21 CFR 111.75(a)(2)(ii)(A) | Component - qualify supplier |
| 15927 | 21 CFR 111.103 | Written procedures - quality control operations |
| 1810 | 21 CFR 211.160(a) | Lab controls established, including changes |
| 1914 | 21 CFR 211.166(a) | Lack of written stability program |
| 4413 | 21 CFR 211.194(a)(8) | Second person sign off |