FDA Inspection
Montclair Hospital, LLCMontclair Hospital, LLC – FDA Inspection, Oct 13, 2010
Record Details
This FDA Inspection record concerns Montclair Hospital, LLC, with an inspection on October 13, 2010, issued by the Center for Biologics Evaluation and Research, covering biologics.
- Company
- Montclair Hospital, LLC
- Inspection Date
- October 13, 2010
- Product Type
- Biologics
View Company Profile
ID · a8737023-511f-46de-b4b0-e3ee93d21034
Inspection Facts
Voluntary Action Indicated (VAI)
Objectionable conditions were found, but FDA is not prepared to take or recommend regulatory action.
- Inspection number
- 694534
- FDA center
- Biologics
- Project area
- Blood and Blood Products
FDA Citations
3- 21 CFR 211.192Quality control unit review of records
- 21 CFR 606.60(b)Equipment calibration frequency
- 21 CFR 606.100(b)Establish, maintain and follow manufacturing SOPs
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Other FDA inspections of Montclair Hospital, LLC
4| Date | Classification | Office | Project area |
|---|---|---|---|
| February 22, 2018 | NAI | Center for Biologics Evaluation and Research | Blood and Blood Products |
| January 14, 2016 | NAI | Center for Biologics Evaluation and Research | Blood and Blood Products |
| March 20, 2014 | NAI | Center for Biologics Evaluation and Research | Blood and Blood Products |
| June 13, 2012 | NAI | Center for Biologics Evaluation and Research | Blood and Blood Products |
Other documents for Montclair Hospital, LLC
- FDA Inspection 1042444 - 2018-02-22
- FDA Inspection 956171 - 2016-01-14
- FDA Inspection 871109 - 2014-03-20
- FDA Inspection 787300 - 2012-06-13
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