Sunstar Americas, Inc.

Warning LetterOpen

Mr. Richard McMahon Managing Director Sunstar Americas, Inc. 301 E. Central Rd. Schaumburg , IL 60195 United StatesFEI 1413787Issued Dec 21, 2021Office of Medical Devices and Radiological Health Operations Div. 2 Central

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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 1413787.

Violations9

Issue DateDec 21, 2021

Product TypeMedical Devices

StatusOpen

Letter Details

Firm: Sunstar Americas, Inc.
Location: Mr. Richard McMahon Managing Director Sunstar Americas, Inc. 301 E. Central Rd. Schaumburg , IL 60195 United States
FEI Number: 1413787
Country: United States
Issue Date: December 21, 2021
Issuing Office: Office of Medical Devices and Radiological Health Operations Div. 2 Central
Product Type: Medical Devices
Status: Open

Summary

Sunstar Americas, Inc. was cited for significant violations of Current Good Manufacturing Practice (CGMP) regulations and Quality System (QS) regulations during a January-February 2021 inspection of its Schaumburg, Illinois facility, which manufactures both pharmaceutical drugs and medical devices including GUM HYDRAL OTC products intended to treat dry mouth. The company's manufacturing methods, facilities, and controls were found to be inadequate, resulting in adulterated drug and device products that did not conform to regulatory standards. The FDA determined that the company's March 2021 response to the inspection findings was insufficient and did not provide adequate evidence of corrective actions necessary to achieve compliance.

Sunstar Americas, Inc. FDA Warning Letter, December 21, 2021