FDA Inspection 1106964 — Essential Pharmaceutical Corp
The FDA completed an inspection of Essential Pharmaceutical Corp on October 17, 2019 in Pomona, CA. The inspection was classified OAI (Official Action Indicated — objectionable conditions were found and regulatory action is recommended). 12 citations were issued during this inspection. Product area: Food/Cosmetics.
Inspection Details
- Classification
- Official Action Indicated (OAI) (OAI)
- End Date
- October 17, 2019
- Fiscal Year
- 2020
- Product Type
- Food/Cosmetics
- Project Area
- Food Composition, Standards, Labeling and Econ
- Location
- Pomona, CA (United States)
Citations
| ID | CFR | Description |
|---|---|---|
| 15511 | 21 CFR 111.27(d) | Equipment - maintain - general |
| 15532 | 21 CFR 111.255(b) | Batch record - complete |
| 15761 | 21 CFR 111.205(b)(1) | Master manufacturing record - specifications; quality |
| 15829 | 21 CFR 111.70(b)(1) | Specifications - component identity |
| 15830 | 21 CFR 111.70(b)(2) | Specifications-component purity, strength, composition |
| 15838 | 21 CFR 111.70(d) | Specifications - labels, packaging |
| 15839 | 21 CFR 111.70(e) | Specifications - identity, purity, strength, composition |
| 15931 | 21 CFR 111.105 | Quality control - packaged, labeled |
| 15932 | 21 CFR 111.105(a) | Quality control - processes, specifications, written procedures |
| 15963 | 21 CFR 111.113(b)(2) | Quality control - reject; specification not met |
| 15981 | 21 CFR 111.123(a)(5) | Quality control operations - reprocessing |
| 16070 | 21 CFR 111.35(b)(2) | Document-equipment date of use, maintain, clean, sanitize |