FDA Inspection 1260555 — A Plus Phlebotomy Services
The FDA completed an inspection of A Plus Phlebotomy Services on February 10, 2025 in Huntingdon Valley, PA. The inspection was classified VAI (Voluntary Action Indicated — objectionable conditions were found but do not meet the threshold for regulatory action). 9 citations were issued during this inspection. Product area: Biologics.
Inspection Details
- Classification
- Voluntary Action Indicated (VAI) (VAI)
- End Date
- February 10, 2025
- Fiscal Year
- 2025
- Product Type
- Biologics
- Project Area
- Blood and Blood Products
- Location
- Huntingdon Valley, PA (United States)
Citations
| ID | CFR | Description |
|---|---|---|
| 15080 | 21 CFR 606.121(c)(12) | Labeling; test results for rel transmitted infections |
| 154 | 21 CFR 606.160(a)(1) | Concurrent documentation |
| 18044 | 21 CFR 610.40(a)(2) | Test for HTLV, syphilis, West Nile, Chagas |
| 18068 | 21 CFR 630.5(d) | CPR certification |
| 18080 | 21 CFR 630.10(e) | Medical History Interview |
| 18103 | 21 CFR 630.15(b)(1) | Medical history and physical exam |
| 4425 | 21 CFR 606.60(a) | Equipment observed, standardized, calibrated |
| 76 | 21 CFR 606.100(b) | Establish, maintain and follow manufacturing SOPs |
| 9261 | 21 CFR 610.40(a) | Test for HIV, HBV, HCV |