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FDA Inspection
•Micra Biotechnologies, Inc.•April 21, 2017

Micra Biotechnologies, Inc. – FDA Inspection, Apr 21, 2017

Record Details

This FDA Inspection record concerns Micra Biotechnologies, Inc., with an inspection on April 21, 2017, issued by the Center for Drug Evaluation and Research, covering drugs.

Company
Micra Biotechnologies, Inc.
Inspection Date
April 21, 2017
Product Type
Drugs
Office
Center for Drug Evaluation and Research
Person
  • Tonia F. Bernard
View Company Profile

ID · b1d37d8c-e19a-4e82-9ea6-28abaa741b82

Inspection Facts

Voluntary Action Indicated (VAI)

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

Inspection number
1010301
FDA center
Human Drugs
Project area
Drug Quality Assurance
Outcome
Form 483 issued

FDA Citations

1
  1. 21 CFR 211.160(a)Following/documenting laboratory controls

Full citation text and observation details available on the Dashboard.

Other FDA inspections of Micra Biotechnologies, Inc.

5
DateClassificationOfficeProject area
August 2, 2024VAICenter for Drug Evaluation and ResearchDrug Quality Assurance
March 10, 2015VAICenter for Drug Evaluation and ResearchDrug Quality Assurance
March 4, 2013VAICenter for Drug Evaluation and ResearchDrug Quality Assurance
January 30, 2012VAICenter for Drug Evaluation and ResearchDrug Quality Assurance
July 23, 2010NAICenter for Drug Evaluation and ResearchDrug Quality Assurance
Other documents for Micra Biotechnologies, Inc.
  • FDA Inspection 1245286 - 2024-08-02
  • FDA Inspection 916518 - 2015-03-10
  • FDA Inspection 819797 - 2013-03-04
  • FDA Inspection 765142 - 2012-01-30
  • FDA Inspection 672872 - 2010-07-23

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