FDA Inspection 854358 — Emu Products and Management, Inc. (EPMI)
The FDA completed an inspection of Emu Products and Management, Inc. (EPMI) on November 1, 2013 in Marlow, OK. The inspection was classified NAI (No Action Indicated — no objectionable conditions were found). 11 citations were issued during this inspection. Product area: Veterinary.
Inspection Details
- Classification
- No Action Indicated (NAI) (NAI)
- End Date
- November 1, 2013
- Fiscal Year
- 2014
- Product Type
- Veterinary
- Project Area
- Monitoring of Marketed Animal Drugs, Feed, and Devices
- Location
- Marlow, OK (United States)
Citations
| ID | CFR | Description |
|---|---|---|
| 15401 | 21 CFR 111.12(b) | Personnel - quality control operations; identified |
| 15405 | 21 CFR 111.13(a) | Supervisor - qualified |
| 15659 | 21 CFR 111.475(b)(1) | Written procedures - holding; distributing |
| 15774 | 21 CFR 111.415(f)(1) | Batch-lot,control number packaged, labeled dietary supplemen |
| 15796 | 21 CFR 111.430(b) | Records - packaging, labeling operations |
| 15809 | 21 CFR 111.570(b)(1) | Written procedures - product complaint; review, investigate |
| 15838 | 21 CFR 111.70(d) | Specifications - labels, packaging |
| 15839 | 21 CFR 111.70(e) | Specifications - identity, purity, strength, composition |
| 15897 | 21 CFR 111.83(a) | Reserve sample - collect, hold |
| 15927 | 21 CFR 111.103 | Written procedures - quality control operations |
| 16057 | 21 CFR 111.535(b)(1) | Records - returned dietary supplement: written procedures |