FDA Inspection 824620 — New York Blood Center Enterprises
The FDA completed an inspection of New York Blood Center Enterprises on May 7, 2013 in Rye, NY. 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). 5 citations were issued during this inspection. Product area: Biologics.
Inspection details
- Classification
- Voluntary Action Indicated (VAI)
- End Date
- May 7, 2013
- Fiscal Year
- 2013
- Product Type
- Biologics
- Project Area
- Blood and Blood Products
- Location
- Rye, NY (United States)
Citations
| ID | CFR | Description |
|---|---|---|
| 1358 | 21 CFR 211.100(b) | SOPs not followed / documented |
| 159 | 21 CFR 606.160(a)(1) | Legibility and indelibility |
| 2619 | 21 CFR 211.198(b)(2) | Complaint Investigation/Follow-Up Findings |
| 630 | 21 CFR 803.17 | Lack of Written MDR Procedures |
| 94 | 21 CFR 606.100(b)(15) | Schedules and procedures for equipment & calibration |