FDA Inspection 1037398 — Eagle Distributors Inc.
The FDA completed an inspection of Eagle Distributors Inc. on Jan 11, 2018 in Los Angeles, CA. The inspection was classified VAI (Voluntary Action Indicated — objectionable conditions or practices were found, but the agency is not prepared to take or recommend any administrative or regulatory action). 6 citations were issued during this inspection. Product area: Drugs.
Inspection details
- Classification
- Voluntary Action Indicated (VAI)
- End Date
- Jan 11, 2018
- Fiscal Year
- 2018
- Product Type
- Drugs
- Project Area
- Drug Quality Assurance
- Location
- Los Angeles, CA (United States)
Citations
| ID | CFR | Description |
|---|---|---|
| 1105 | 21 CFR 211.22(d) | Procedures not in writing, fully followed |
| 1879 | 21 CFR 211.180(c) | Records not made readily available to FDA |
| 1942 | 21 CFR 211.180(e) | Records reviewed annually |
| 2008 | 21 CFR 211.186(a) | Written procedures followed |
| 2019 | 21 CFR 211.188(b)(7) | Documentation of Actual Yield and Theoretical Yield |
| 4401 | 21 CFR 211.186(b)(9) | Complete instructions, procedures, specifications et. al. |