FDA Inspection 1120143 — James P. Lin, M.D., Inc.
The FDA completed an inspection of James P. Lin, M.D., Inc. on March 5, 2020 in Corona, CA. The inspection was classified VAI (Voluntary Action Indicated — objectionable conditions were found but do not meet the threshold for regulatory action). 3 citations were issued during this inspection. Product area: Biologics.
Inspection Details
- Classification
- Voluntary Action Indicated (VAI) (VAI)
- End Date
- March 5, 2020
- Fiscal Year
- 2020
- Product Type
- Biologics
- Project Area
- Blood and Blood Products
- Location
- Corona, CA (United States)
Citations
| ID | CFR | Description |
|---|---|---|
| 12241 | 21 CFR 1271.55(b)(4) | Reasons for ineligibility on summary |
| 12272 | 21 CFR 1271.65(b)(2) | Labeled re: biohazard, risks, test results |
| 12277 | 21 CFR 1271.75(a)(1) | Risk factors, clinical evidence |