Inspections, Compliance, Enforcement, and Criminal Investigations
Barton-Carey Products, Inc. 12/10/12
Department of Health and Human Services
|Public Health Service|
Food and Drug Administration
|Cincinnati District Office|
6751 Steger Drive
Cincinnati, OH 45237-3097
Telephone: (513) 679-2700
FAX: (513) 679-2771
DEC 10, 2012
John H. Mays
Barton-Carey Products, Inc.
1331 Conant Street, Suite 102
Maumee, OH 43537-1665
Dear Mr. Mays:
During an inspection of your firm located in Maumee, Ohio, on August 6-10, 2012, an investigator from the United States Food and Drug Administration (FDA) determined that your firm is the specification developer of medical support stocking (compression garments). 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 function of the body.
The inspection revealed that the compression garment is adulterated under section 501(f)(1)(B) of the Act, 21 U.S.C. 351(f)(1)(B), because your firm does not have an approved application for premarket approval (PMA) in effect pursuant to section 515(a) of the Act, 21 U.S.C. 360e(a), or an approved application for an investigational device exemption (IDE) under section 520(g) of the Act, 21 U.S.C. 360j(g). The compression garment is also misbranded under section 502(o) the Act, 21 U.S.C. 352(o), because your firm did not notify the agency of your intent to introduce the device into commercial distribution in that a notice or other information respecting the new intended use of the device was not provided to the FDA as required by section 510(k), 21 U.S.C. 360(k), and 21 C.F.R. 807.81(a)(3)(ii).
Specifically, the compression garment was cleared under K854428 with the indications for the leg only. However, your firm is marketing the device for all parts of the body, including the arm, torso, ankle, and head. Additionally, new treatments have been added, such as thrombophlebitis. For a device requiring premarket approval, the notification required by section 510(k) of the Act, 21 U.S.C. 360(k), is deemed satisfied when a PMA is pending before the agency (21 C.F.R. 807.81(b)).
The compression garment is also misbranded under section 502(o) the Act, 21 U.S.C. 352(o), because your firm did not notify the agency of your intent to introduce the device into commercial distribution in that a notice or other information respecting the modification to the device was not provided to the FDA as required by section 510(k), 21 U.S.C. 360(k), and 21 C.F.R. 807.81(a)(3)(i).
Specifically, your firm has modified the compression garment, cleared under K854428, by giving the customer the option of adding a 1/4 inch zipper. This change potentially affects the effectiveness (compression) of the device. For a device requiring premarket approval, the notification required by section 510(k) of the Act, 21 U.S.C. 360(k), is deemed satisfied when a PMA is pending before the agency (21 C.F.R. 807.81(b)). The kind of information your firm needs to submit in order to obtain approval or clearance for your device is described on the Internet at http://www.fda.gov/cdrh/devadvice/3122.html. The FDA will evaluate the information your firm submits and decide whether your product may be legally marketed.
This inspection also 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 (CGMP) requirements of the Quality System (QS) regulation found at Title 21, Code of Federal Regulations (CFR), Part 820. We received a response from John B. Mays, Director of RA/QA dated August 29, 2012, concerning our investigator’s observations noted on the Form FDA 483, List of Inspectional Observations (FDA 483) that was issued to you. 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 adequate procedures for implementing corrective and preventive actions, as required by 21 CFR 820.100(a).
Specifically, your firm’s “Corrective and Preventive Action” procedure, 50.101, dated 09/11/09, does not define the criteria for determining when a corrective and/or preventive action (CAPA) should be initiated. Your Director of RA/QA stated that all quality internal and external nonconformances are considered a CAPA. Your “Complaint Handling” procedure and “Non-Conforming Product” procedure do not address actions needed to correct and prevent recurrence of nonconforming product; verification or validation of the corrective action to ensure that it is effective and that it does not adversely affect the finished device; nor do these procedures address documenting all corrective and preventive action activities.
For example, the 9 complaints and 2 nonconformance reports reviewed did not document an investigation into the cause of the nonconformities; and identification of the action(s) needed to correct and prevent recurrence of nonconforming product.
Additionally, your Director of RA/QA stated the following 3 trends were identified during data analyses within the last year: 1) An employee incorrectly recording glove lengths on work orders and was retrained; 2) Employees not completing work orders correctly and they were retrained; and 3) An increase in the number of complaints of holes in the compression garments, which resulted in changing the size of the needles used in production. No CAPAs were opened to address these trends, and these quality problems and the corrective actions taken were not documented.
The response dated August 29, 2012 cannot be assessed at this time. Your response states that you are drafting a new corrective and preventive action procedure, as well as complaint handling and non-conformance handling procedures. It also states that a retrospective review of all complaints, nonconformances and CAPA records will be reviewed to determine if appropriate corrective actions have been conducted. Please provide an update on the progress of these corrective actions.
2. Failure to establish and maintain adequate procedures for the identification, documentation, validation or, where appropriate, verification, review, and approval of design changes before their implementation, as required by 21 CFR 820.30(i). Specifically;
Your “Design Control” procedure 15.103, dated 02/01/00 does not address how design changes will be identified, verified, validated, documented and implemented.
For example, the option of adding a zipper to the compression garment was added in early 2000. This change was not evaluated or documented under design controls, and has not been verified and/or validated.
The response dated August 29, 2012 cannot be assessed at this time. Your response states that you will revise the design control procedure to define and establish how design changes will be identified, implemented, documented, verified and/or validated. It also states that a retrospective review of all design changes will be completed and corrective action will be taken. Additionally the entire Design History File will be reviewed to ensure full compliance with 21 CFR 820.30. Please provide an update on the progress of these corrective actions.
3. Failure to establish and maintain adequate procedures for receiving, reviewing, evaluating, and investigating complaints of possible failures of the device by a formally designated unit, as required by 21 CFR 820.198(a) - (c). Specifically;
a) Your “Complaint Handling” procedure, 65.101, dated 09/11/09, states that a “customer feedback form” is only to be completed for complaints “for devices determined to be controllable by the company”. Therefore, only complaints designated as “Internal Replacements” are considered complaints. The 4 “External Complaints” reviewed were only documented on a work order form. The following information required under 21 CFR 820.198(a) and (b) was not documented: 1) All information needed from the complainant; 2) An evaluation to determine whether the complaint represents an event which is required to be reported to FDA under part 803 of 21 CFR, Medical Device Reporting; 3) A review and evaluation to determine whether an investigation is necessary.
b) All 9 “Internal Replacement” complaints reviewed, which involved the possible failure of the device to meet its specifications, were not investigated, where necessary
The response dated August 29, 2012 cannot be assessed at this time. Your response states that you will revise the complaint handling procedure to define and establish how complaints will be processed, evaluated and investigated to include a requirement to assess each complaint for MDR reportablility. It also states a retrospective review of all complaint records received in the last 2 years will be conducted to determine compliance with 21 CFR 820.198. Please provide an update on the progress of these corrective actions.
4. Failure to establish and maintain data that clearly describe or reference the specified requirement, including quality requirements, for purchased or otherwise received product and services, as required by 21 CFR 820.50(b).
For example, there are no specified requirements for your suppliers of the fabric used to manufacture the compression garments.
The response dated August 29, 2012 cannot be assessed at this time. Your response states that you will establish a new purchasing control procedure to ensure that all purchased product and services conform to specified requirements, and suppliers are evaluated to include the type and extent of control needed for each supplier. Additionally, component specification, supplier change notifications, and signed contracts will be documented. Please provide an update on the progress of these corrective actions.
5. Failure to maintain a device master record, that contains or refers to, device specifications including appropriate drawings, composition, formulation, and component specifications, as required by 21 CFR 820.181(a). Specifically, the component specifications for the fabric, dyes, silicon beads, and inkjet prints used to manufacture the compression garments are not documented.
The response dated August 29, 2012 cannot be assessed at this time. Your response states that you are re-establishing and implementing revisions to your component specifications to reflect additional detail. Please provide an update on the progress of these corrective actions.
Our inspection also revealed that your devices are misbranded under section 502(t)(2) of the Act, 21 U.S.C. 352(t)(2), in that your firm failed or refused to furnish material or information respecting the device that is required by or under section 519 of the Act, 21 U.S.C. § 360i, and 21 CFR Part 803 - Medical Device Reporting (MDR) regulation. Significant deviations include, but are not limited to, the following:
Failure to develop, maintain, and implement written MDR procedures, as required by 21 CFR 803.17. For example, your firm’s MDR procedure titled “Medical Device Reporting” procedure, 65.102, dated 02/01/00, does not establish a process that meets the requirements of 21 CFR 803.17.
The response dated August 29, 2012 cannot be assessed at this time. Your response states that you will establish a new complaint handling procedure that includes the requirements to assess each complaint for MDR reportablility. It also states a retrospective review of all complaint records received in the last 2 years to determine if any of the complaints should have been reported as MDRs. Please provide an update on the progress of these corrective actions.
You should take prompt action to correct the violations addressed in this letter. Failure to promptly correct these violations may result in regulatory action being initiated by the Food and Drug Administration without further notice. These actions include, but are not limited to, seizure, injunction, and/or civil money penalties. Also, federal agencies are advised of the issuance of all Warning Letters about devices so that they may take this information into account when considering the award of contracts. Additionally, premarket approval applications for Class III devices to which the Quality System regulation deviations are reasonably related will not be approved until the violations have been corrected. Requests for Certificates to Foreign Governments will not be granted until the violations related to the subject devices have been corrected.
Please notify this office in writing within fifteen working days from the date you receive this letter of the specific steps that you have taken to correct the noted violations, including an explanation of how you plan to prevent these violations, or similar violations, from occurring again. Include documentation of the corrective action you have taken. If your planned corrections will occur over time, please include a timetable for implementation of those corrections. If corrective action cannot be completed within 15 working days, state the reason for the delay and the time within which the corrections will be completed.
Your response should be sent to: Ms. Gina Brackett, Compliance Officer, Food and Drug Administration, 6751 Steger Drive, Cincinnati, Ohio 45237. If you have any questions about the content of this letter please contact Ms. Brackett at (513) 679-2700, ext. 2167, or by facsimile at (513) 679-2773.
Finally, you should know that this letter is not intended to be an all-inclusive list of the violations at your facility. It is your responsibility to ensure compliance with applicable laws and regulations administered by FDA. The specific violations noted in this letter and in FDA 483 issued at the closeout of the inspection may be symptomatic of serious problems in your firm’s manufacturing and quality assurance systems. You should investigate and determine the causes of the violations, and take prompt actions to correct the violations and to bring your products into compliance.
Paul J. Teitell