FDA Inspection 848290 — GE PHARMA LLC
The FDA completed an inspection of GE PHARMA LLC on September 13, 2013 in North Haven, CT. The inspection was classified OAI (Official Action Indicated — objectionable conditions were found and regulatory action is recommended). 6 citations were issued during this inspection. Product area: Food/Cosmetics.
Inspection Details
- Classification
- Official Action Indicated (OAI) (OAI)
- End Date
- September 13, 2013
- Fiscal Year
- 2013
- Product Type
- Food/Cosmetics
- Project Area
- Food Composition, Standards, Labeling and Econ
- Location
- North Haven, CT (United States)
Citations
| ID | CFR | Description |
|---|---|---|
| 15659 | 21 CFR 111.475(b)(1) | Written procedures - holding; distributing |
| 15790 | 21 CFR 111.403 | Written procedures - labeling operations |
| 15797 | 21 CFR 111.553 | Written procedures - product complaint |
| 15841 | 21 CFR 111.70(f) | Specifications - product received for packaging, labeling |
| 16014 | 21 CFR 111.140(b)(1) | QC ops; written procedures; material review, disposition |
| 16042 | 21 CFR 111.503 | Written procedures - returned dietary supplement |