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# CGMP and QS Violations in Sunstar Inspection
- URL: https://www.fdaweb.com/cgmp-and-qs-violations-in-sunstar-inspection/
- Published: 2022-01-18T12:00:00.000Z
- Updated: 2026-09-14T17:28:58.000Z
- Author: David McFarland
- Tags: Drugs, Devices, #legacy-id-D5150944

A 1/12-2/18/21 FDA inspection at Sunstar Americas’ drug and medical device manufacturing facility in Schaumburg, IL, found significant violations of Current Good Manufacturing Practice (CGMP) regulations for finished pharmaceuticals and Quality System regulations for medical devices. A just-released 12/21/21 [Warning Letter](https://www.fda.gov/inspections-compliance-enforcement-and-criminal-investigations/warning-letters/sunstar-americas-inc-614058-12212021?ref=fdaweb.com) says specific violations were: 

- failing to establish adequate written procedures for production and process control designed to assure that the drug products the company manufactures have the identity, strength, quality, and purity they purport or are represented to possess and to follow all of the written production and process control procedures;
- 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 had already been distributed;
- failing to establish laboratory controls that include scientifically sound and appropriate specifications, standards, sampling plans, and test procedures designed to assure that components, drug product containers, closures, in-process materials, labeling, and drug products conform to appropriate standards of identity, strength, quality, and purity;
- failing to establish an adequate quality control unit with the responsibility and authority to approve or reject all components, drug product containers, closures, in-process materials, packaging materials, labeling, and drug products;
- failing to adequately validate a medical device manufacturing process whose results cannot be fully verified by subsequent inspection and test through established procedures;
- failing to adequately establish procedures for corrective and preventive action, including the documentation of such activities;
- failing to adequately establish schedules for the adjustment, cleaning, and other maintenance of equipment; and
- failing to adequately establish procedures for medical device design input.

FDA says the firm’s quality systems are inadequate and recommends that it engage a qualified consultant to assist it in meeting drug CGMP requirements.

The letter acknowledges the firm’s commitment to suspend drug production at the facility.

Sunstar was told to correct the violations promptly and to respond with a list of specific steps it has taken since the inspection to correct the violations and prevent their recurrence, with a schedule for completing the corrections.