FDA Inspection 1187485 — Neway Medical, P.C.
The FDA completed an inspection of Neway Medical, P.C. on November 8, 2022 in New York, NY. The inspection was classified VAI (Voluntary Action Indicated — objectionable conditions were found but do not meet the threshold for regulatory action). 7 citations were issued during this inspection. Product area: Biologics.
Inspection Details
- Classification
- Voluntary Action Indicated (VAI) (VAI)
- End Date
- November 8, 2022
- Fiscal Year
- 2023
- Product Type
- Biologics
- Project Area
- Human Cellular, Tissue, and Gene Therapies
- Location
- New York, NY (United States)
Citations
| ID | CFR | Description |
|---|---|---|
| 12222 | 21 CFR 1271.47(a) | Design of procedures to ensure compliance |
| 12239 | 21 CFR 1271.55(b)(2) | Listing and interpretation of CD tests performed |
| 12242 | 21 CFR 1271.55(c) | Name and personal info on accompanying records |
| 12245 | 21 CFR 1271.55(d)(1)(ii) | Results, interpretation of CD screening |
| 12247 | 21 CFR 1271.55(d)(2) | Accurate, indelible, legible |
| 12277 | 21 CFR 1271.75(a)(1) | Risk factors, clinical evidence |
| 12279 | 21 CFR 1271.75(b) | Risk factors, leukocyte-rich cells or tissues |