FDA Inspection 1205562 — Jeffrey M. Steinberg MD, Inc., A Professional Medical Corporation
The FDA completed an inspection of Jeffrey M. Steinberg MD, Inc., A Professional Medical Corporation on May 16, 2023 in Encino, CA. The inspection was classified VAI (Voluntary Action Indicated — objectionable conditions were found but do not meet the threshold for regulatory action). 6 citations were issued during this inspection. Product area: Biologics.
Inspection Details
- Classification
- Voluntary Action Indicated (VAI) (VAI)
- End Date
- May 16, 2023
- Fiscal Year
- 2023
- Product Type
- Biologics
- Project Area
- Human Cellular, Tissue, and Gene Therapies
- Location
- Encino, CA (United States)
Citations
| ID | CFR | Description |
|---|---|---|
| 12229 | 21 CFR 1271.50(a) | Determination based on screening and testing |
| 12242 | 21 CFR 1271.55(c) | Name and personal info on accompanying records |
| 12272 | 21 CFR 1271.65(b)(2) | Labeled re: biohazard, risks, test results |
| 12277 | 21 CFR 1271.75(a)(1) | Risk factors, clinical evidence |
| 12282 | 21 CFR 1271.75(d) | Donors with risks not determined ineligible |
| 12493 | 21 CFR 1271.90(c) | Eligibility not required--warning labels |