Department of Health and Human Services
|Public Health Service|
Food and Drug Administration
|New England District Office|
One Montvale Avenue, 4th floor
Stoneham, MA 02180
CMS # 460224
UNITED PARCEL SERVICE
September 24, 2015
Kevin J. Boulay
548 Main Road
Tiverton, RI 02878.
Dear Mr. Boulay:
The Food and Drug Administration (FDA) conducted an inspection of your firm’s medical device operations at Medsource, Inc., 548 Main Road, Tiverton, RI from March 26 through 31, 2015. During the inspection, an investigator from the United States FDA determined that your firm is a manufacturer and distributor of medical devices, including orthopedic surgical instrument trays. 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 your response, dated April 13, 2015, which responded to the Form FDA 483, List of Inspectional Observations, issued to your firm on March 31, 2015. Our comments regarding the adequacy of your response are described below. Your significant violations are as follows:
1. Failure to establish and maintain procedures for the control of storage areas and stock rooms for products to prevent mix-ups, damage, deterioration, contamination or other adverse effects pending use or distribution and to ensure that no obsolete, rejected, or deteriorated product is used or distributed, as required by 21 CFR 820.150(a). Specifically, your firm did not have a procedure for storage of medical devices when asked by our investigator.
In addition, orthopedic trays awaiting delivery to customers were observed stored immediately in an area also used to inspect orthopedic trays returning to your firm after being utilized in surgery. Also, a container housing gasoline was observed immediately next to orthopedic trays and other instrument trays.
2. Failure to establish acceptance activities for the manufacture of your orthopedic trays, as required by 21 CFR 820.80(a). Specifically, your firm did not have any acceptance activities when asked by our investigator, even those devices being returned to your facility for further distribution.
3. Failure to establish and maintain procedures for verifying or validating corrective and preventive actions (CAPA), as required by 21 CFR 820.100(a). Specifically, your firm did not have a CAPA procedure when asked by our investigator.
4. Failure to establish procedures to ensure management with executive responsibility review the suitability and effectiveness of the quality system at defined intervals and with sufficient frequency to ensure the quality system satisfies the requirements of 21 CFR Part 820.20. Specifically, your firm did not have procedures for management review and/or quality systems, no quality plan and/or quality policy has been established, and management reviews are not conducted.
Your firm’s response to the above violations was determined to be inadequate. Your response did include some promised corrective actions to the above items, however, they did not include appropriate documentation to ensure these items have been corrected.
Title 21 of the Code of Federal Regulations Part 807.20 requires any establishment engaged in the manufacture, preparation, propagation, compounding, assembly, or processing of a device intended for human use to register and submit listing information for those devices in commercial distribution. Since you are modifying surgical trays and the surgical tray does not remain the same after it is modified but instead becomes a new device (with the placement of additional medical devices in the surgical tray), then you are considered a manufacturer and are required to register and list your establishment. Under section 502(o) of the Act, 21 U.S.C. § 352(o), a device that is manufactured, prepared, propagated, compounded, or processed in an establishment not duly registered under section 510 is deemed to be misbranded.
Please be aware that significantly changing the instrumentation and/or labeling provided as part of an orthopedic device system (e.g. orthopedic surgical trays) may change the intended use of the device, which would cause the devices distributed by your firm to be misbranded under section 502(o) of the Act, 21 U.S.C. § 352(o) and adulterated under section 501(f)(1)(B) of the Act, 21 U.S.C. § 351(f)(1)(B), because your firm would have introduced or delivered into interstate commerce for commercial distribution devices with major changes or modifications to the intended use without submitting a new premarket application to FDA as required by section 510(k) of the Act, 21 U.S.C. § 360(k), and 21 CFR 807.81(a)(3)(ii) and because they may be a class III device under section 513(f), 21 U.S.C. § 360c(f), and would not have an approved application for premarket approval in effect pursuant to section 515(a), 21 U.S.C. § 360e(a) or an approved application for an investigational device exemption under section 520(g), 21 U.S.C. § 360j(g).
Please also be aware that the product you distribute, Optecure + CCC (Allograft Demineralized Bone Matrix + CCC), is a medical device. 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 are intended to affect the structure or function of the body. Demineralized Bone Matrix (DBM), when not combined with any other component (e.g., sodium hyaluronate, glycerol, or calcium phosphate), is regulated as human cells, tissues, and cellular and tissue-based products (HCT/P’s) under section 361 of the Public Health Service Act. However, when Demineralized Bone Matrix is combined with bone void filler, the ensuing product is considered to be a medical device. As a medical device, this device is subject to 21 U.S.C. § 351(h) in that the methods used in, or the facilities or controls used for its manufacture, packing, storage, or installation should be in conformity with the Current Good Manufacturing Practice (CGMP) requirements for devices which were promulgated under 21 U.S.C. § 360j(f)(1)(A) and set forth in the Quality System regulation, as specified in Title 21, Code of Federal Regulations (CFR), Part 820. Failure to meet these regulations will result in a violation of Section 501(h), 21 U.S.C. § 351(h).
Your firm 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 FDA without further notice. These actions include, but are not limited to, seizure, injunction, and civil money penalties. Also, federal agencies may be advised of the issuance of 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 violations 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 business days from the date you receive this letter of the specific steps your firm has taken to correct 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 all violations included in this Warning Letter.
Please send your reply to the Food and Drug Administration, Attention: Karen Archdeacon, One Montvale Avenue, Stoneham, MA 02180. If you have questions regarding any issues in this letter, please contact Ms. Archdeacon at 781-587-7491.
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 the violations, and take prompt actions to correct the violations and bring the products into compliance.
Acting District Director
New England District Office