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U.S. Department of Health and Human Services

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Enforcement Actions

Michigan Medical Innovations 6/5/12

  

Department of Health and Human Services' logoDepartment of Health and Human Services

Public Health Service
Food and Drug Administration
 

Detroit District
300 River Place
Suite 5900
Detroit . Ml 48207
Telephone: 313-393-81 00
FAX: 313-393-8139

WARNING LETTER
2012-DET-16

June 5, 2012

VIA UPS

Mr. Robert F. Kraal
President
Michigan Medical Innovations
481 Pettis Avenue, SE
Ada, MI 49301-9540

Dear Mr. Kraal:

During an inspection of your firm located in Ada, Michigan, from April 2, 2012, through April 16, 2012, an Investigator from the United States Food and Drug Administration (FDA) determined that your firm manufactures the DVT Care CA5 Compression Limb Sleeve. Under section 201(h) of the Federal Food, Drug, and Cosmetic Act (the Act), 21 U.S.C. § 321(h), this product is a device because it is 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.

This inspection revealed that this device is 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, its 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 Dick Smith, QA Manager, dated April 27, 2012, concerning our Investigator's observations noted on the Form FDA 483, List of Inspectional Observations that was issued to you. We address this response below, in relation to each of the noted violations. The violations found during the inspection and subsequent review include, but are not limited to, the following:

1. Failure to establish and maintain 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). For example, your firm 's procedures QSM 1113 "DESIGN CONTROL" (Rev. A, Date: Jan. 2012) and QOP-7301 "DESIGN CONTROLS" (Rev. A, Date: 04/01/05) describe the controlled process for "device modifications and all updates and require all design changes to be initiated (b)(4). However, thirty-six of forty nine design, software and device were initiated (b)(4) and following your procedures, to include:

a. Revision 41: initiated due to (b)(4)
b. Revision 45: initiated due to (b)(4)
c. Revision 62: initiated due to (b)(4)

2. Failure to establish and maintain procedures for implementing corrective and preventive actions required by 21 CFR 820.100. For example:

a. Your procedures QSM 1151 "CORRECTIVE AND PREVENTIVE ACTION "(Rev. A, Date: Jan 2012) and QOP-85-04 "CORRECTIVE AND PREVENTIVE ACTION"(Rev. A, no effective date) state (b)(4), however, the procedures fail to indicate the means and frequency of analysis pertaining to quality data sources as required by 21 CFR 820.100(a).

3. Failure to document all activities required under 21 CFR 820.100 and their results, as required by 21 CFR 820.100(b). For example:

a. Product Nonconformity Report (PNR) 1197 documents that due to a (b)(4) you implemented the corrective action (b)(4)  and the preventive action of contract manufacturer (b)(4). These actions were not documented in the CAPA system.
b. PNR 1176 documents that due to a (b)(4) you implemented the corrective action of (b)(4) and the preventive action of (b)(4). These actions were not documented in the CAPA system.
c. PNR 1196 documents (b)(4) the corrective action (b)(4) and preventive action (b)(4). These actions were not documented in the CAPA system.
d. PNR 1198 documents (b)(4) and the corrective action of (b)(4) and the preventive action (b)(4). These actions were not documented in the CAPA system.

4. Failure to adequately ensure that, where the results of a process cannot be fully verified by subsequent inspection and test, the process is validated with a high degree of assurance and approved according to established procedures, as required by 21 CFR 820.75(a).  For example, your procedure QSM 1113 "DESIGN CONTROL" (Rev. A, Date: Jan 2012) states (b)(4). QOP-75-03 "VALIDATION OF PROCESSES & SOFTWARE" (Rev. A, no effective date) and QSM 1132 "VALIDATION OF PROCESSES & SOFTWARE" (Rev. A, Date: Jan 2012) state (b)(4). However, your firm has not validated in-process and finish device testing apparati and processes that ensure the device is being manufactured according to your specifications to include:

a. Valve Assembly Test Kit
b. Battery Tester
c. Final functionality Testing
d. Proper Valve Installation 

5. Failure to adequately establish and maintain procedures to control product that does not conform to specified requirements, as required by 21 CFR 820.90.  For example:

a. Your firm's procedures QSM 1157 "CONTROL OF NONCONFORMING PRODUCTS" (Rev. A, Date: Jan) and procedure QOP-83-01 "CONTROL OF NONCONFORMING PRODUCTS" (Rev. A, no effective date) state (b)(4). However, the FDA Investigator observed the following:

i. Two power harness components were noted in the reject bin and were later reworked; however, a PNR was not initiated.
ii. Design revision 45, implemented due to a vent valve failing to open, was a result of valves failing in-process inspection, however, no PNR was initiated.

b. Your firm's procedures QSM 1157 "CONTROL OF NONCONFORMING PRODUCTS" (Rev. A, Date: Jan) and procedure QOP-83-01 "CONTROL OF NONCONFORMING PRODUCTS" (Rev. A, no effective date) do not require documentation of the evaluation of non-conformances to determine the need for an investigation, as required by 21 CFR 820.90(b); and for the documentation of rework and re-evaluation activities in the Device History Record (DHR), as required by 21 CFR 820.90(c).  

6. Failure to adequately establish and maintain procedures for acceptance of incoming product to ensure conformity to specified requirements, as required by 21 CFR 820.80(b). For example, you do not conduct inspection or testing of critical incoming components to include: circuit boards, valves, pumps, and custom batteries.

7. Failure to adequately establish and maintain procedures for receiving, reviewing, and evaluating complaints, as required by 21 CFR 820.198(a). For example: your firm's procedures QSM 1149 "CUSTOMER COMPLAINTS" (Rev. A, Date: Jan 2012) and QOP-85-3 "CUSTOMER COMPLAINTS" (Rev. A, Date: no effective date):

a. Fail to address the process by which your firm receives, reviews and evaluates complaints from your distributors; who are listed in the device user manual as the contact for complaints.
b. Indicate device complaints are formally investigated when they involve a possible failure of a device, labeling, or packaging to meet any of its specifications; however, device complaints 080511 , 0106121 , 0111111, and 0527112 document device failures, but your firm did not initiate a formal investigation regarding these failures.
c. Indicate complaint records include a complaint category classification, brief description of the complaint, response to the complainant, whether the complaint is reportable, whether a formal investigation of the complaint was initiated, and if not, the reason; however, complaints 080511, 0106121, 0111111, and 0527112 fail to include information required by the procedures to include: complaint category classification, response to the complainant, whether the complaint is reportable, whether or not a formal investigation of the complaint was initiated and, if not the reason no investigation was made and complaints 0511102 and 062811 failed to include a brief description of the complaint.

8. Failure to establish and maintain adequate procedures to ensure that complaints are evaluated to determine whether they represent an event that is required to be reported to FDA under part 803, Medical Device Reporting (MDR), as required by 21 CFR 198(b). For example:

a. Your firm's procedures QSM 1149 "CUSTOMER COMPLAINTS" (Rev. A, Date: Jan 2012) and QOP-85-03 "CUSTOMER COMPLAINTS" (Rev.
A, Date: no effective date) fail to define complaint evaluation criteria for determining whether a complaint represents a reportable event.
b. Eleven of eleven complaint records reviewed failed to contain sufficient complainant information to effectively evaluate the complaint for MDR
c. reportability, and did not include the reasons for the absence of information and subsequent MDR evaluation.

9. Failure to adequately establish and maintain procedures for the requirements, including quality requirements that must be met by suppliers, contractors, and consultants, as required by 21 CFR 820.50. For example:

a. Your procedures QSM 1127 "SUPPLIER EVALUATION AND MONITORING" (Rev. A, Date: Jan 2012) and QOP-74-01 "SUPPLIER EVALUATION AND MONITORING" (Rev. A, no effective date) state (b)(4) however, your firm was unable to provide documentation to demonstrate your initial and/or follow-up evaluation of your current suppliers, as required by your procedures and 21 CFR 820.50(a).
b. There was no purchasing data to demonstrate that components received from your vendors conform to specified requirements as required by 21 CFR 820.50(b).  Additionally, your procedures QSM 1125 "PURCHASING" (Rev. A, Date: Jan 2012) and QOP-74-02" PURCHASING " (Rev. A, no effective date) state (b)(4), however, your purchasing documents do not contain this statement. 

10. Failure to establish procedures for identifying training needs and ensure that all personnel are trained to adequately perform their assigned responsibilities, as required by 21 CFR 820.25(b). For example, your procedures QSM 1168 "COMPETENCE, AWARNESS, AND TRAINING" (Rev. A, Date: Jan 2012) and QOP-62-01 "COMETENCE, AWARNESS AND TRAINING" (Rev. A, no effective date) identify training requirements and training needs, however, you have no documentation to demonstrate that staff to include: the Development Engineer; Assembly Manager; staff competing validation or verification activities; and staff receiving and reviewing complaints and CAP A's have been properly trained to perform the functions of their jobs.

11 . Failure of management with executive responsibility to review the suitability and effectiveness of the quality system at defined intervals and with sufficient frequency according to established procedures to ensure the quality system satisfies the requirements of part 820, and the manufacturer's established quality policy and objectives. The dates and results of quality system reviews shall be documented, as required by 21 CFR 820.20(c). For example, your procedures QSM 1105 "MANAGEME T REVIEW" (Rev. A, Date: Jan 2012), and QOP-56-01 "MANAGEMENT REVIEW" (Rev. A, no effective date) require management reviews to be conducted (b)(4) however, your firm stated the quality system has never been reviewed for suitability or effectiveness.

12. Failure to establish adequate procedures for quality audits and to conduct such audits to assure the quality system is in compliance with established quality system requirements and to determine the effectiveness of the quality system, as required by 21 CFR 820.22. Your firm's quality audit procedure QSM 1106 "INTERNAL QUALITY AUDITS" (Rev. A, Date: Jan 2012) (Exhibit 32), and QOP-82-02 "INTERNAL QUALITY AUDITS" no effective date) require all major quality system processes to be audited (b)(4) however, your firm has not conducted any internal quality audits.

13. Failure to maintain adequate procedures to control all documents, as required by 21 CFR 820.40.  For example, your firm’s procedures QSM 1124 "CONTROL OF DOCUMENTS" (Rev. A, Date: Jan 2011) and QOP-42-01 "CONTROL OF DOCUMENTS" (Rev. A, no effective date) indicate controlled documents are to be identified by: (b)(4).  However, your procedures, to include:

a. QSM 1124 "CONTROL OF DOCUMENTS" (Rev. A, Date: Jan 2011) and QOP-42-01 "CONTROL OF DOCUMENTS" (Rev. A, no effective date)
b. QSM 1125 "PURCHASING" (Rev. A, Date: Jan 2012) and QOP-74-02 "PURCHASING " (Rev. A, no effective date)
c. QSM 1157 "CONTROL OF NONCONFORMING PRODUCTS" (Rev. A, Date: Jan) and procedure QOP-83-01 "CONTROL OF NONCONFORMING PRODUCTS" (Rev. A, no effective date) demonstrate that your previous procedures fail to include the (b)(4), and your current procedures revisions do not include identification of the (b)(4). Additionally, your past and present procedures are all documented as revision (b)(4).

We have reviewed your response dated 4/27/2012. Your response is inadequate in that the corrections listed in your response, have not been implemented. 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. 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 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 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: CDR Kimberly Y. Martin, Compliance Officer, Detroit District Office, Food and Drug Administration, HFR-CE7560, 101 W. Ohio Street, Suite 500, Indianapolis, Indiana 46204. If you have any questions about the contents of this letter, please contact CDR Martin at 317-226-6500 ext. 116.

Finally, 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 the 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 action to correct the violations and bring the devices into compliance.

Sincerely yours,

/s/

Glenn T. Bass
District Director
Detroit District Office