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FDA Inspection
•Dura Medical Equipment Dba Bay Shore Dura Medical•August 24, 2010

Dura Medical Equipment Dba Bay Shore Dura Medical – FDA Inspection, Aug 24, 2010

Record Details

This FDA Inspection record concerns Dura Medical Equipment Dba Bay Shore Dura Medical, with an inspection on August 24, 2010, issued by the Center for Drug Evaluation and Research, covering drugs.

Company
Dura Medical Equipment Dba Bay Shore Dura Medical
Inspection Date
August 24, 2010
Product Type
Drugs
Office
Center for Drug Evaluation and Research
View Company Profile

ID · 6b463af5-4937-4e47-b303-2c21249a970c

Inspection Facts

Voluntary Action Indicated (VAI)

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

Inspection number
678263
FDA center
Human Drugs
Project area
Drug Quality Assurance

FDA Citations

2
  1. 21 CFR 211.84(d)(1)Identity Testing of Each Component
  2. 21 CFR 211.186(a)Signature and checking of records -- 2 persons

Full citation text and observation details available on the Dashboard.

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