FDA Inspection 1047420 — United Exchange Corporation
The FDA completed an inspection of United Exchange Corporation on April 6, 2018 in Cypress, CA. The inspection was classified OAI (Official Action Indicated — objectionable conditions were found and regulatory action is recommended). 4 citations were issued during this inspection. Product area: Drugs.
Inspection Details
- Classification
- Official Action Indicated (OAI) (OAI)
- End Date
- April 6, 2018
- Fiscal Year
- 2018
- Product Type
- Drugs
- Project Area
- Drug Quality Assurance
- Location
- Cypress, CA (United States)
Citations
| ID | CFR | Description |
|---|---|---|
| 1105 | 21 CFR 211.22(d) | Procedures not in writing, fully followed |
| 1111 | 21 CFR 211.25(a) | Training , Education , Experience overall |
| 2419 | 21 CFR 211.198(a) | Complaint Handling Procedure |
| 3616 | 21 CFR 211.165(d) | Acceptance criteria for sampling & testing |