| Public Health Service Food and Drug Administration |
Kansas City District |
Department of Health and Human ServicesMarch 23, 2011
CERTIFIED MAIL
RETURN RECEIPT REQUESTED
WARNING LETTER
Ref. KAN 2011-06
Melvin L Roche, President
BC Group International, Inc.
3081 Elm Point Industrial Dr.
St. Charles, MO 63301
Dear Mr. Roche:
During all inspection of your firm located on November 15, 2010 through November 23, 2010 an investigator from the United States Food and Drug Administration (FDA) determine that your firm manufactures Class II medical devices such as the DA-2006 and DA-2006P Defibrillator Analyzers. 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.
This inspection revealed that the DA-2006 and DA-2006P Defibrillator Analyzers 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) requirement of the Quality System (QS) regulation found at Title 21, Code of Federal Regulations (CFR), Part 820.
1. Failure to ensure that when the results of a process cannot be fully verified by subsequent inspection and test that the process shall be validated with a high degree of assurance and approved according to established procedures, as required by 21 CFR 820.75(a).
For example, the process validation for the wave soldering machine used for circuit boards in the DA-2006 and DA-2006P defibrillator testers is not documented. According to Mr. Roche, there is no process validation documented for the wave soldering process
2. Failure to establish and maintain process control procedures that describe any process controls necessary to ensure conformance to specifications where deviations from device specifications could occur as a result of the manufacturing process, as required by 21 CFR 820.70(a).
For example there are no written procedures specifying wave soldering parameters for circuit boards used in the DA-2006 and DA-2006P defibrillator testers. Mr. Roche stated that your firm did not have any procedures for wave soldering of circuit boards used in all products lines.
3. Failure to adequately ensure that formal documented reviews of the design results are planned and conducted at appropriate stages of the device's design development and to ensure that the results of a design review, including identification of the design, the date, and the individual(s) performing the review are documented in the design history file (the DHF), as required by 21 CFR 820.30(e).
For example, the investigator reviewed your firm's DHR for the DA-2006 and DA-2006P defibrillator testers on 11/22/2010 and found no documented design reviews. Mr. Roche, indicated the evidence of the meetings is informal emails rather than documented reviews.
Our inspection also revealed that the DA-2006 and DA-2006P Defibrillator Analyzers are adulterated under section 501(f)(1)(B)of the Act, 21 U.S.C. 351(f)(1)(B), because you do not have an approved application for premarket approval (PMA) in effect pursuant of 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 devices are also misbranded under section 502(o) of the Act, 21 U.S.C. 352(o), because you did not notify the agency of your 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) of the Act, 21 U.S.C. 360(k), is deemed satisfied when a PMA is pending before the agency [21 CFR 807.81(b)] The kind of information you need 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 you submit and decide whether your product may be legally marketed.
You should take prompt action to correct the violation(s) addressed in this letter. Failure to promptly correct these violation(s) 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 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.
This letter is not intended to be an all-inclusive list of the violation(s) at your facility. It is your responsibility to ensure compliance with applicable laws and regulations administered by FDA. The specific violation(s) noted in this letter and in the Inspectional Observations, Form FDA 483 (FDA 483), issued at the closeout of the inspection may be symptomatic of serious problems in your firm's manufacturing and quality management systems. You should investigate and determine the causes of the violation(s), and take prompt actions to correct the violation(s) and to bring your products into compliance.
Please notify this office in writing within fifteen (15) business days from the date you receive this letter of the specific steps you have taken to correct the noted violations, as well as an explanation of how you plan to prevent these violation(s), or similar violation(s) from occurring again. Include documentation of the corrections and/or corrective actions you have taken. If your planned corrections and/or corrective actions will occur over time, please include a timetable for implementation of these activities. If corrections and/or corrective actions cannot be completed within 15 business days, state the reason for the delay and the time within which these activities will be completed. Your response should be comprehensive and address all violations included in this WL.
Your response should be sent to: Matthew A. Walburger, Compliance Officer, at the address above. If there are any questions about the content of this letter please contact Mr. Walburger at (913)752-2104.
Sincerely,
/S/
John W. Thorsky
District Director
Kansas City District
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