MEDDEV USA, INC. 10/09/12
| || |
Department of Health and Human Services
|Public Health Service|
Food and Drug Administration
| ||Dallas District|
4040 North Central Expressway
Dallas, Texas 75204-3128
October 9, 2012
UPS OVERNIGHT MAIL
Jolie G. Slaton
Owner and President
MEDDEV USA, Inc.
100 Highland Park Village, Suite 200
Dallas, Texas 75205
Dear Ms. Slaton:
During an inspection of your firm located in Dallas, Texas, on May 9 through May 11, 2012, an investigator from the United States Food and Drug Administration (FDA) determined that your firm manufactures medical devices, including Portal Vein Cannula. 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. These violations include, but are not limited to, the following:
Quality System (QS) Regulation
1. Failure to establish and maintain adequate procedures to control the design of the device in order to ensure that the specified design requirements are met, as required by 21 CFR 820.30(a).
Specifically, your firm does not have design control procedures that address the following design activities of the Portal Vein Cannula: design inputs, design outputs, design review, design verification, design validation, design transfer, design changes, and design history record.
2. Failure to establish and maintain adequate procedures for validating the device design to ensure that the devices conform to defined user needs and intended uses. The design validation shall include risk analysis and design validation results shall be documented, as required by 21 CFR 820.30(g).
Specifically, your firm has not performed and documented risk analysis for the Portal Vein Cannula devices distributed in (b)(4).
3. Failure to establish and maintain adequate procedures for implementing corrective and preventive action, as required by 21 CFR 820.100(a).
Specifically, your firm does not have any written procedures for corrective and preventive action.
4. Failure to establish and maintain adequate procedures for receiving, reviewing, and evaluating complaints by a formally designated unit, as required by 21 CFR 820.198(a).
Specifically, your firm does not have written procedures for complaint handling.
5. Failure to establish and maintain adequate procedures for acceptance activities, including inspections, tests, or other verification activities. Acceptance or rejection shall be documented, as required by 21 CFR 820.80(a).
Specifically, your firm does not have written procedures for inspections, tests, or other verification activities for the Portal Vein Cannula and does not have records of acceptance or rejection.
6. Failure to maintain adequate Device Master Records (DMRs) to include or refer to the location of device specifications, production process specifications, quality assurance procedures, and packaging and labeling specifications, and to ensure that each DMR is prepared and approved in accordance with 21 CFR 820.40, as required by 21 CFR 820.181.
Specifically, your firm does not have a DMR for the Portal Vein Cannula.
7. Failure to maintain adequate Device History Records (DHRs) for each batch, lot, or unit to demonstrate that the device is manufactured in accordance with the DMR, as required by 21 CFR 820.184.
Specifically, your firm did not have DHRs for (b)(4) of the Portal Vein Cannula manufactured and distributed in (b)(4).
8. Failure to establish and maintain adequate procedures to ensure that all purchased or otherwise received product and services conform to specified requirements, as required by 21 CFR 820.50.
Specifically, your firm does not have purchasing control procedures for the Portal Vein Cannula. Additionally, your firm has not evaluated the ability of the foreign contract manufacturer for its ability to meet specified requirements, including quality requirements.
9. Failure to establish adequate quality policy and quality objectives for, and commitment to, quality, as required by 21 CFR 820.20(a).
Specifically, your firm does not have a quality policy and quality objectives for the manufacture of the Portal Vein Cannula.
MEDICAL DEVICE REPORTING
Our inspection also revealed that your firm’s Portal Vein Cannula 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. Significant violations include, but are not limited to, the following:
Failure to develop, maintain, and implement adequate written Medical Device Reporting (MDR) procedures, as required by 21 CFR 803.17.
Specifically, your firm does not have any MDR procedures.
Our inspection also revealed that your devices, the Portal Vein Cannula,are 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 under section 520(g) of the Act, 21 U.S.C. § 360j(g). The device is also misbranded under section 502(o) the Act, 21 U.S.C. § 352(o), because your firm did not notify the agency of its intent to introduce the device into commercial distribution, as required by section 510(k) of the Act, 21 U.S.C. § 360(k). For a device requiring premarket approval, the notification required by section 510(k) is deemed satisfied when a PMA is pending before the agency in accordance with [21 CFR 807.81(b)]. The kind of information that your firm needs to submit in order to obtain approval or clearance for the device is described on the Internet at: http://www.fda.gov/MedicalDevices/DeviceRegulationandGuidance/HowtoMarketYourDevice/default.htm
. The FDA will evaluate the information that your firm submits and decide whether the product may be legally marketed.
Establishment Registration and Device Listing
Under section 510 of the Act (21 U.S.C. § 360), manufacturers of medical devices are required to annually register with the FDA. In September 2007, section 510 of the Act was amended by the Food and Drug Administration Amendments Act of 2007 (Pub. L. 110-85) to require domestic and foreign device establishments to submit their annual establishment registration and device listing information to FDA by electronic means [section 510(p) of the Act (21 U.S.C. § 360(p))] during the period beginning October 1st and ending December 31st of each year. Our records indicate that your firm has not fulfilled annual registration and listing requirements.
Therefore, all of your firm’s devices are misbranded within the meaning of section 502(o) of the Act, 21 U.S.C. § 352(o), in that the devices were manufactured, prepared, propagated, compounded, or processed in an establishment not duly registered under section 510 of the Act, 21 U.S.C. § 360, and were not included in a list required by section 510(j) of the Act, 21 U.S.C. § 360(j).
A follow-up inspection will be required to assure that corrections and/or corrective actions are adequate. 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 (including any systemic corrective actions) 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.
Your firm’s response should be sent to: Mr. Thao Ta, Compliance Officer, Dallas District Office, U.S. Food and Drug Administration, HFR-SW140, 4040 N. Central Expressway, Suite 300, Dallas, Texas 75204. If you have any questions about the contents of this letter, please contact: Mr. Ta at 214-253-5217.
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.
Reynaldo R. Rodriguez, Jr.
Dallas District Director