FDA Inspection 718519 — ACM Medical Laboratory, Inc. Unity Hospital
The FDA completed an inspection of ACM Medical Laboratory, Inc. Unity Hospital on Apr 5, 2011 in Rochester, 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). 4 citations were issued during this inspection. Product area: Biologics.
Inspection Details
- Classification
- Voluntary Action Indicated (VAI)
- End Date
- Apr 5, 2011
- Fiscal Year
- 2011
- Product Type
- Biologics
- Project Area
- Blood and Blood Products
- Location
- Rochester, NY (United States)
Citations
| ID | CFR | Description |
|---|---|---|
| 159 | 21 CFR 606.160(a)(1) | Legibility and indelibility |
| 4413 | 21 CFR 211.194(a)(8) | Second person sign off |
| 9087 | 21 CFR 600.14(a)(1) | Who must report - receiving information |
| 94 | 21 CFR 606.100(b)(15) | Schedules and procedures for equipment & calibration |