Owens & Minor, Inc. dba American Contract Systems, Inc.
Warning LetterOpen
Edward A. Pesicka
President & Chief Executive Officer
Owens & Minor, Inc. dba American Contract Systems, Inc.
9130 Lockwood Boulevard
Mechanicsville , VA 23116
United States
edpesicka@owens-minor.comFEI 3008492337Issued Nov 1, 2024Center for Devices and Radiological Health
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 3008492337.
Violations4
Issue DateNov 1, 2024
Product TypeMedical Devices
StatusOpen
Letter Details
Firm
Owens & Minor, Inc. dba American Contract Systems, Inc.
Location
Edward A. Pesicka
President & Chief Executive Officer
Owens & Minor, Inc. dba American Contract Systems, Inc.
9130 Lockwood Boulevard
Mechanicsville , VA 23116
United States
edpesicka@owens-minor.com
FEI Number
3008492337
Country
United States
Issue Date
November 01, 2024
Issuing Office
Center for Devices and Radiological Health
Product Type
Medical Devices
Status
Open
Summary
Owens & Minor, Inc. dba American Contract Systems, Inc. manufactured sterile convenience kits, including C-Section Packs, that were found to be adulterated due to failure to comply with Current Good Manufacturing Practice (CGMP) requirements under 21 CFR Part 820. A critical violation involved the company's failure to establish and maintain procedures for accepting incoming products, including inadequate inspection, testing, and verification of conformity to specified requirements, with documented instances occurring at least four times between January and July 2024. The FDA inspection was conducted August 5-14, 2024 at the company's Tiffin, Ohio facility, and the company submitted a response to the investigator's observations in September 2024.
Owens & Minor, Inc. dba American Contract Systems, Inc. FDA Warning Letter, November 1, 2024
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