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FDA Inspection
•Cody Laboratories, Inc.•December 8, 2017

Cody Laboratories, Inc. – FDA Inspection, Dec 8, 2017

Record Details

This FDA Inspection record concerns Cody Laboratories, Inc., with an inspection on December 8, 2017, issued by the Center for Drug Evaluation and Research, covering drugs.

Company
Cody Laboratories, Inc.
Inspection Date
December 8, 2017
Product Type
Drugs
Office
Center for Drug Evaluation and Research
People
  • Christopher M. Jenner (FDA Associated Person)
  • Nayan J. Patel (FDA Associated Person)
View Company Profile

ID · b308265c-5212-4184-840c-74dc8afdd53d

Inspection Facts

Voluntary Action Indicated (VAI)

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

Inspection number
1034453
FDA center
Human Drugs
Project area
Drug Quality Assurance
Outcome
Form 483 issued

FDA Citations

1
  1. 21 CFR 211.68(b)Computer control of master formula records

Full citation text and observation details available on the Dashboard.

Other FDA inspections of Cody Laboratories, Inc.

5
DateClassificationOfficeProject area
October 30, 2014VAICenter for Drug Evaluation and ResearchDrug Quality Assurance
October 12, 2012VAICenter for Drug Evaluation and ResearchDrug Quality Assurance
February 18, 2011VAICenter for Drug Evaluation and ResearchDrug Quality Assurance
August 27, 2010VAICenter for Drug Evaluation and ResearchUnapproved and Misbranded Drugs
July 24, 2009VAICenter for Drug Evaluation and ResearchDrug Quality Assurance
Other documents for Cody Laboratories, Inc.
  • FDA Inspection 902313 - 2014-10-30
  • FDA Inspection 805118 - 2012-10-12
  • FDA Inspection 712399 - 2011-02-18
  • FDA Inspection 682313 - 2010-08-27
  • FDA Inspection 612683 - 2009-07-24

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