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FDA Inspection
•Northeast Laboratories, Inc.•December 2, 2011

Northeast Laboratories, Inc. – FDA Inspection, Dec 2, 2011

Record Details

This FDA Inspection record concerns Northeast Laboratories, Inc., with an inspection on December 2, 2011, issued by the Center for Drug Evaluation and Research, covering drugs.

Company
Northeast Laboratories, Inc.
Inspection Date
December 2, 2011
Product Type
Drugs
Office
Center for Drug Evaluation and Research
View Company Profile

ID · bd23511e-0cff-43fd-9885-4c57530d26b9

Inspection Facts

Voluntary Action Indicated (VAI)

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

Inspection number
755765
FDA center
Human Drugs
Project area
Drug Quality Assurance

FDA Citations

2
  1. 21 CFR 211.160(b)Scientifically sound laboratory controls
  2. 21 CFR 211.194(a)(8)Second person sign off

Full citation text and observation details available on the Dashboard.

Other FDA inspections of Northeast Laboratories, Inc.

3
DateClassificationOfficeProject area
January 11, 2024NAICenter for Drug Evaluation and ResearchDrug Quality Assurance
March 29, 2017VAICenter for Drug Evaluation and ResearchDrug Quality Assurance
February 4, 2010NAICenter for Drug Evaluation and ResearchDrug Quality Assurance
Other documents for Northeast Laboratories, Inc.
  • FDA Inspection 1229261 - 2024-01-11
  • FDA Inspection 1006525 - 2017-03-29
  • FDA Inspection 643538 - 2010-02-04

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