FDA Inspection
ACM Medical Laboratory, Inc. Unity HospitalACM Medical Laboratory, Inc. Unity Hospital – FDA Inspection, Apr 5, 2011
Record Details
This FDA Inspection record concerns ACM Medical Laboratory, Inc. Unity Hospital, with an inspection on April 5, 2011, issued by the Center for Biologics Evaluation and Research, covering biologics.
- Inspection Date
- April 5, 2011
- Product Type
- Biologics
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ID · 6f7f7cfd-ccc2-4918-9802-f30550875f4d
Inspection Facts
Voluntary Action Indicated (VAI)
Objectionable conditions were found, but FDA is not prepared to take or recommend regulatory action.
- Inspection number
- 718519
- FDA center
- Biologics
- Project area
- Blood and Blood Products
FDA Citations
4- 21 CFR 600.14(a)(1)Who must report - receiving information
- 21 CFR 211.194(a)(8)Second person sign off
- 21 CFR 606.160(a)(1)Legibility and indelibility
- 21 CFR 606.100(b)(15)Schedules and procedures for equipment & calibration
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Other FDA inspections of ACM Medical Laboratory, Inc. Unity Hospital
1| Date | Classification | Office | Project area |
|---|---|---|---|
| December 7, 2012 | VAI | Center for Biologics Evaluation and Research | Blood and Blood Products |
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