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FDA Inspection
•Remington Davis Inc•January 27, 2017

Remington Davis Inc – FDA Inspection, Jan 27, 2017

Record Details

This FDA Inspection record concerns Remington Davis Inc, with an inspection on January 27, 2017, issued by the Center for Drug Evaluation and Research, covering drugs.

Company
Remington Davis Inc
Inspection Date
January 27, 2017
Product Type
Drugs
Office
Center for Drug Evaluation and Research
Person
  • Karen M. Cooper (Company Rep)
View Company Profile

ID · 9008a8ef-3be7-4d89-9302-5009fbd908c5

Inspection Facts

Official Action Indicated (OAI)

Significant objectionable conditions were found and regulatory or administrative action is recommended.

Inspection number
1002423
FDA center
Human Drugs
Project area
Bioresearch Monitoring
Outcome
Form 483 issued

FDA Citations

3
  1. 21 CFR 312.60FD-1572, protocol compliance
  2. 21 CFR 312.62(b)Case history records- inadequate or inadequate
  3. 21 CFR 312.62(a)Accountability records

Full citation text and observation details available on the Dashboard.

Other FDA inspections of Remington Davis Inc

2
DateClassificationOfficeProject area
July 10, 2019NAICenter for Drug Evaluation and ResearchBioresearch Monitoring
October 22, 2018NAICenter for Drug Evaluation and ResearchBioresearch Monitoring
Other documents for Remington Davis Inc
  • FDA Inspection 1097339 - 2019-07-10
  • FDA Inspection 1072627 - 2018-10-22

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