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# CGMP Violations at Sterling Pharmaceutical
- URL: https://www.fdaweb.com/cgmp-violations-at-sterling-pharmaceutical/
- Published: 2022-10-04T12:00:00.000Z
- Updated: 2026-09-14T18:01:46.000Z
- Author: David McFarland
- Tags: Drugs, #legacy-id-D5152886

A 2/7-2/18 FDA inspection at Sterling Pharmaceutical Services, Dupo, IL, found significant violations of current good manufacturing practice (CGMP) regulations for finished drugs. A 9/27 [Warning Lette](https://www.fda.gov/inspections-compliance-enforcement-and-criminal-investigations/warning-letters/sterling-pharmaceutical-services-llc-629019-09272022?ref=fdaweb.com)r also says agency review of several product labels determined that the products are legally considered to be unapproved new drugs. It says the firm’s poor manufacturing practices are particularly concerning because many of its products are ophthalmic and directed for use in young children.

The letter says specific violations were:

- failing to thoroughly investigate any unexplained discrepancy or failure of a batch or any of its components to meet any of its specifications, whether or not the batch has already been distributed;
- failing to establish an adequate system for monitoring environmental conditions in aseptic processing areas; and
- failing to establish and follow appropriate written procedures that are designed to prevent microbiological contamination of drug products purporting to be sterile, including validation of all aseptic and sterilization processes.

The letter includes statements from the labels reviewed during the inspection that establish that the products are legally considered drugs, including some that are labeled as homeopathic drugs.

“Significant findings in this letter demonstrate that your firm does not operate an effective quality system in accord with CGMP,” the letter says. “In addition to the lack of effective production operations oversight to ensure reliable facilities and equipment, we found your quality unit is not enabled to exercise proper authority and/or has insufficiently implemented its responsibilities. You should immediately and comprehensively assess your company’s global manufacturing operations to ensure that systems, processes, and the products manufactured conform to FDA requirements.”

The letter reminds Sterling that it is responsible for the quality of drugs you produce as a contract facility, regardless of agreements in place with product owners.

FDA recommends the company engage a qualified consultant to assist it in meeting CGMP requirements.

Sterling was told to respond with a list of specific steps it has taken to address the violations and prevent their recurrence, with a schedule for completing the corrections.