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FDA Inspection
•Laurel Regional Hospital•August 16, 2010

Laurel Regional Hospital – FDA Inspection, Aug 16, 2010

Record Details

This FDA Inspection record concerns Laurel Regional Hospital, with an inspection on August 16, 2010, issued by the Center for Biologics Evaluation and Research, covering biologics.

Company
Laurel Regional Hospital
Inspection Date
August 16, 2010
Product Type
Biologics
Office
Center for Biologics Evaluation and Research
View Company Profile

ID · 6cc69174-a404-43c2-9da8-815246e18a7a

Inspection Facts

Voluntary Action Indicated (VAI)

Objectionable conditions were found, but FDA is not prepared to take or recommend regulatory action.

Inspection number
678455
FDA center
Biologics
Project area
Blood and Blood Products

FDA Citations

3
  1. 21 CFR 606.100(c)Thorough investigations
  2. 21 CFR 211.22(d)Procedures not in writing, fully followed
  3. 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 Laurel Regional Hospital

1
DateClassificationOfficeProject area
September 21, 2009VAICenter for Biologics Evaluation and ResearchBlood and Blood Products
Other documents for Laurel Regional Hospital
  • FDA Inspection 614581 - 2009-09-21

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