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FDA Inspection
•STI Pharma LLC•July 21, 2016

STI Pharma LLC – FDA Inspection, Jul 21, 2016

Record Details

This FDA Inspection record concerns STI Pharma LLC, with an inspection on July 21, 2016, issued by the Center for Drug Evaluation and Research, covering drugs.

Company
STI Pharma LLC
Inspection Date
July 21, 2016
Product Type
Drugs
Office
Center for Drug Evaluation and Research
View Company Profile

ID · 39eb4d74-f4e9-436e-b7c0-0029d7c31638

Inspection Facts

Official Action Indicated (OAI)

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

Inspection number
977705
FDA center
Human Drugs
Project area
Bioresearch Monitoring

FDA Citations

1
  1. 21 CFR 314.80(b)Failure to develop written procedures

Full citation text and observation details available on the Dashboard.

Other FDA inspections of STI Pharma LLC

1
DateClassificationOfficeProject area
May 17, 2017NAICenter for Drug Evaluation and ResearchBioresearch Monitoring
Other documents for STI Pharma LLC
  • FDA Inspection 1013491 - 2017-05-17

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