FDA Inspection
South Nassau Communities HospitalSouth Nassau Communities Hospital – FDA Inspection, May 1, 2012
Record Details
This FDA Inspection record concerns South Nassau Communities Hospital, with an inspection on May 1, 2012, issued by the Center for Biologics Evaluation and Research, covering biologics.
- Inspection Date
- May 1, 2012
- Product Type
- Biologics
View Company Profile
ID · b5de6ac0-03fd-4d8f-b7b3-7c14d755c8d2
Inspection Facts
Voluntary Action Indicated (VAI)
Objectionable conditions were found, but FDA is not prepared to take or recommend regulatory action.
- Inspection number
- 778439
- FDA center
- Biologics
- Project area
- Blood and Blood Products
FDA Citations
5- 21 CFR 606.170(a)Adverse Reaction - Investigations
- 21 CFR 640.3(a)Donor suitability by means of medical history
- 21 CFR 606.160(a)(1)Concurrent documentation
- 21 CFR 606.20(b)Qualifications of responsible personnel
- 21 CFR 606.100(b)Establish, maintain and follow manufacturing SOPs
Full citation text and observation details available on the Dashboard.
Other FDA inspections of South Nassau Communities Hospital
4| Date | Classification | Office | Project area |
|---|---|---|---|
| August 23, 2016 | NAI | Center for Biologics Evaluation and Research | Blood and Blood Products |
| June 29, 2016 | NAI | Center for Biologics Evaluation and Research | Blood and Blood Products |
| April 21, 2014 | VAI | Center for Biologics Evaluation and Research | Blood and Blood Products |
| June 4, 2010 | VAI | Center for Biologics Evaluation and Research | Blood and Blood Products |
Other documents for South Nassau Communities Hospital
- FDA Inspection 984313 - 2016-08-23
- FDA Inspection 974958 - 2016-06-29
- FDA Inspection 875482 - 2014-04-21
- FDA Inspection 667716 - 2010-06-04
Document or profile
One record shows the event. A profile shows the pattern.
Buy this document for the source file and details behind this single event.
Choose full profile access to connect related records, sites, people, citations, and enforcement history in one view.