WARNING LETTER
Owens & Minor, Inc. dba American Contract Systems, Inc.
MARCS-CMS 695683 —
November 01, 2024
Delivery Method:
VIA Electronic Mail
Product:
Medical Devices
Recipient:
Recipient Name
Edward A. Pesicka
Recipient Title
President & Chief Executive Officer
Owens & Minor, Inc. dba American Contract Systems, Inc.
9130 Lockwood Boulevard
Mechanicsville
,
VA
23116
United States
edpesicka@owens-minor.com
Issuing Office:
Center for Devices and Radiological Health
United States
WARNING LETTER
CMS # 695683
Dear Mr. Pesicka:
During an inspection of your firm, American Contract Systems, (ACS) Inc., in Tiffin OH, FEI 3008492337, on August 5 through 14, 2024, an investigator from the United States Food and Drug Administration (FDA) determined that your firm manufactures sterile convenience kits, such as the C-Section Pack (pack number WECS27G). Under section 201(h) of the Federal Food, Drug, and Cosmetic Act (the Act), 21 U.S.C. § 321(h), these products are devices because they are intended for use in the diagnosis of disease or other conditions or in the cure, mitigation, treatment, or prevention of disease, or to affect the structure or any function of the body.
This inspection revealed that these devices are adulterated within the meaning of section 501(h) of the Act, 21 U.S.C. § 351(h), in that the methods used in, or the facilities or controls used for, their manufacture, packing, storage, or installation are not in conformity with the current good manufacturing practice requirements of the Quality System regulation found at Title 21,
Code of Federal Regulations
(CFR), Part 820.
We received a response from Daniel R. Wright, VP, Global QARA, Owens & Minor, Inc., dated September 5, 2024, concerning our investigator’s observations noted on the Form FDA 483 (FDA 483), List of Inspectional Observations, that was issued to your firm. We address this response below, in relation to each of the noted violations. These violations include, but are not limited to, the following:
1. Failure to establish and maintain procedures for acceptance of incoming product to ensure that incoming product is inspected, tested, or otherwise verified as conforming to specified requirements, and that acceptance or rejection is documented, as required by 21 CFR 820.80(b). For example:
On at least four occasions, from January 2024 through July 2024, your firm accepted sterilization bag lots (86149183, 86471442, 86740750, 86149178) that failed your thickness requirements. Your Receiving Procedure, RV-01, includes minimum and maximum acceptance criteria for these bags to ensure they are free from defects that may adversely affect gas injection, sealing, or diffusion characteristics during your ethylene oxide (EO) sterilization processes. Acceptance activities for these 4 lots were being performed by ACS personnel at sister facilities in Florida. Each of these lots were deemed acceptable and the lots were used for EO processing at this Tiffin, OH facility, as well as other ACS facilities.
We reviewed your firm’s response and concluded that it is not adequate. You indicated that CAPA 2024-0021 was opened but did not provide a copy that describes the preventive actions you are planning to address this serious observation.
Your response states that on August 6, 2024, you placed a hold on all raw material sterilization bags at all ACS locations, including Tiffin, OH. All finished goods in ACS manufacturing locations and O&M distribution centers were then placed on distribution hold on August 7, 2024, while you investigated these failures. Your investigation included performing a retest of all available bags in inventory at your Fort Myers facility and you indicated that all retests passed your specifications. However, your response did not provide a systemic response describing how your firm will prevent this significant failure from recurring.
(b)(4)
2. Failure to establish and maintain procedures to control the design of the device in order to ensure that specified design requirements are met, as required by 21 CFR 820.30(a).
You did not implement your Design Control Procedure, DE-01.
Specifically, your firm has not completed design verification and validation activities for 25 different FDA product codes in use at this facility, to ensure that all components being placed in your convenience kits have been reviewed and verified to undergo your sterilization process, as required by 21 CFR 820.30(g).
For example, two out of 26 components that are included in your C-Section Pack (pack number WECS27G) have not been verified as acceptable for your EO sterilization process. The “CAUTERY| ES ROCKER COATED SMOKE EVAC NS” is classified as a “medium” risk component and there was no documentation that this component was evaluated, as required by your “design verification and validation activities” that are described in your design control procedure.
Your Design Control Procedure, DE-01, requires component evaluation be performed as part of your design verification and validation process, including your C-Section Pack, designated as FDA Code OHM, class 2. The procedure also requires that all these review records be included in the design history file.
Also, your firm did not have complete design history files for 25 different FDA product codes being manufactured at your facility, as required by 21 CFR 820.30(j).
We reviewed your firm’s response and concluded that it is not adequate. You acknowledged documentation indicating component approval for products was lacking at this facility and were not part of your DHF’s. You now plan to remediate all components and approve all DHFs, by January 31, 2025, in part to ensure that all components being placed in your convenience kits have been reviewed and verified to undergo your sterilization process. Your firm did not provide enough detail to describe how you plan on prioritizing and implementing this review for all 25 product codes in use at this location.
(b)(4)
. As part of your response to this observation, please describe how you will complete this review of components to ensure that only devices with complete DHF’s, including complete component evaluations, are currently being distributed.
(b)(4)
Your firm should take prompt action to address any violations identified in this letter. Failure to adequately address this matter may result in regulatory action being initiated by the FDA without further notice. These actions include, but are not limited to, seizure, injunction, and civil money penalties.
Other federal agencies may take your compliance with the FD&C Act and its implementing regulations into account when considering the award of federal contracts. Additionally, should FDA determine that you have Quality System regulation violations that are reasonably related to premarket approval applications for Class III devices, such devices will not be approved until the violations have been addressed. Should FDA determine that your devices or facilities do not meet the requirements of the Act, requests for Certificates to Foreign Governments (CFG) may not be granted.
Please notify this office in writing within fifteen business days from the date you receive this letter of the specific steps your firm has taken to address the noted violations, as well as an explanation of how your firm plans to prevent these violations, or similar violations, from occurring again. Include documentation of the corrections and/or corrective actions (which must address systemic problems) that your firm has taken. If your firm’s planned corrections and/or corrective actions will occur over time, please include a timetable for implementation of those activities. If corrections and/or corrective actions cannot be completed within fifteen business days, state the reason for the delay and the time within which these activities will be completed. Your firm’s response should be comprehensive and address any violations included in this Warning Letter. If you believe that your products are not in violation of the FD&C Act, include your reasoning and any supporting information for our consideration as part of your response.
Your firm’s response should be sent by email to CDRHWarningLetterResponses@fda.hhs.gov. Refer to CMS case # 695683 when replying. If you have any questions about the contents of this letter, please contact: Gina Brackett, EAT Assistant Director at (513) 288-7055 or gina.brackett@fda.hhs.gov.
Finally, you should know that this letter is not intended to be an all-inclusive list of the violations at your firm’s facility. It is your firm’s responsibility to ensure compliance with applicable laws and regulations administered by FDA. The specific violations noted in this letter and in the Inspectional Observations, FDA 483, issued at the close of the inspection may be symptomatic of serious problems in your firm’s manufacturing and quality management systems. Your firm should investigate and determine the causes of any violations and take prompt actions to address any violations and bring the products into compliance.
Sincerely yours,
/S/
RDML Sean M. Boyd, MPH, USPHS
Director
Office of Regulatory Programs
Office of Product Evaluation and Quality
Center for Devices and Radiological Health
Cc:
(b)(4)
, Operations Manager,
(b)(4)
@owens-minor.com
Content current as of:
11/12/2024
Regulated Product(s)
Medical Devices