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# Inspection Issues at Sagent’s Plattsburgh Facility
- URL: https://www.fdaweb.com/inspection-issues-at-sagents-plattsburgh-facility/
- Published: 2023-01-04T12:00:00.000Z
- Updated: 2026-09-14T18:10:31.000Z
- Author: David McFarland
- Tags: Drugs, #legacy-id-D5153448

A 9/21/21-11/4/21 FDA inspection at the Plattsburgh, NY, drug outsourcing facility acquired by Sagent Pharmaceuticals identified serious deficiencies in the firm’s practices for producing drug products intended to be sterile. A just-released 7/27/22 [Warning Letter](https://www.fda.gov/inspections-compliance-enforcement-and-criminal-investigations/warning-letters/sagent-pharmaceuticals-inc-636636-07272022?ref=fdaweb.com) says violations of the Federal Food, Drug, and Cosmetic Act included adulterated drug products due to being prepared, packed, or held under insanitary conditions, and violations of current good manufacturing practices.

The letter acknowledges that Sagent voluntarily ceased production and distribution of all aseptically produced products at the facility as of 10/5/21 and advised FDA of its intent to resume distribution of sterile products on or after a redacted date. It also acknowledges a Sagent 11/12/21 recall of certain lots of drug products intended to be sterile that were within expiry date, due to a lack of sterility assurance. FDA further acknowledges that the firm voluntarily destroyed redacted in-process lots in 3/2022 and 5/2/2022\. Finally, it acknowledges the company’s “intent to continue \[the voluntary destruction\] process with the remaining redacted lots within inventory.”

The letter says the agency was unable to evaluate some of the firm’s proposed corrective actions due to a lack of supporting documentation.

FDA says it “strongly recommends that your management undertake a comprehensive assessment of operations, including facility design, procedures, personnel, processes, maintenance, materials, and systems. In particular, this review should assess your aseptic processing operations. We also recommend a third-party consultant with relevant sterile drug manufacturing expertise to assist you in conducting this comprehensive evaluation.”

Sagent was told to respond with a list of specific steps it has taken to address any violations, with a schedule for completing the corrections.