Sagent Pharmaceuticals, Inc.

Warning LetterOpen

Dr. Peter A. Kaemmerer Chief Executive Officer Sagent Pharmaceuticals, Inc. SterRx, LLC 1901 N. Roselle Road Suite 450 Schaumburg , IL 60195 United StatesFEI 3010840309Issued Jul 27, 2022Division Pharmaceutical Quality Operations I

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Source: FDA, published letter. FDA published this warning letter; View Letter opens FDA's copy. To check it, open FDA's record for this establishment, listed under FEI 3010840309.

Violations8

Issue DateJul 27, 2022

Product TypeDrugs

StatusOpen

Letter Details

Firm: Sagent Pharmaceuticals, Inc.
Location: Dr. Peter A. Kaemmerer Chief Executive Officer Sagent Pharmaceuticals, Inc. SterRx, LLC 1901 N. Roselle Road Suite 450 Schaumburg , IL 60195 United States
FEI Number: 3010840309
Country: United States
Issue Date: July 27, 2022
Issuing Office: Division Pharmaceutical Quality Operations I
Product Type: Drugs
Status: Open

Summary

Sagent Pharmaceuticals' outsourcing facility was cited for serious deficiencies in manufacturing practices for sterile drug products that violated Current Good Manufacturing Practice (CGMP) regulations and put patients at risk. FDA inspectors identified critical failures in the facility's aseptic processing procedures during a September-November 2021 inspection, leading the company to voluntarily cease production of all aseptically processed products in October 2021 and initiate a recall of approximately (b)(4) lots of sterile drug products lacking sterility assurance. The company subsequently committed to destroying in-process lots and notified FDA of its intent to resume sterile product distribution after implementing corrective measures.

Sagent Pharmaceuticals, Inc. FDA Warning Letter, July 27, 2022