Inspections, Compliance, Enforcement, and Criminal Investigations
InControl Medical, LLC 11/9/12
Department of Health and Human Services
|Public Health Service|
Food and Drug Administration
Minneapolis District Office
November 9, 2012
RETURN RECEIPT REQUESTED
Refer to MIN 13 – 08
Herschel Q. Peddicord
President and Chief Executive Officer
InControl Medical, LLC
3225 Gateway Road, Suite 250
Brookfield, Wisconsin 53045
Dear Mr. Peddicord:
During an inspection of your firm, InControl Medical, LLC, located at 3225 Gateway Road, Brookfield, Wisconsin, on August 14-16, 21, 2012, an investigator from the Food and Drug Administration (FDA) determined that your firm manufactures the InTone™ non-implanted electrical stimulator indicated for use in the treatment of female urinary incontinence. 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 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 (21 CFR), Part 820.
We received a response from Mitchell H. Maritato, Vice President of Manufacturing, dated September 7, 2012, concerning our investigator’s observations noted on the Form FDA 483, List of Inspectional Observations, that was issued to your firm on August 21, 2012. We address this response below.
Violations include, but are not limited to, the following:
1. Failure to establish and maintain an adequate organizational structure to ensure that devices are designed and produced in accordance with 21 CFR 820, as required by 21 CFR 820.20(b). Specifically, your firm has not:
A. Established the appropriate responsibility, authority, and interrelation for all personnel who manage, perform, and assess work affecting quality, and has not provided the independence and authority necessary to perform these tasks;
B. Provided adequate resources, including the assignment of trained personnel for the management, performance of work, and assessment activities, including internal quality audits, to meet the requirements of 21 CFR 820; and
C. Appointed, and documented the appointment of, a management representative who:
i. Has established authority over and responsibility for ensuring quality system requirements are effectively established and maintained; and
ii. Reports on the performance of the quality system to management with executive responsibility through management review.
2. Failure to perform quality audits, which is required by 21 CFR 820.22. Specifically, quality audits have not been performed to determine whether the quality system activities and results comply with quality system procedures. An internal audit schedule does not exist. Additionally, the procedure, “Quality System Audit Management,” QP82-001, Revision 1, step (b)(4), states “Quality is responsible for setting annual audit schedules. The department is also responsible for….” Step (b)(4) states “A list of qualified Auditors and Lead Auditors is maintained…by the Quality manager or designee.” Your firm does not have a Quality department or a position titled Quality manager.
3. Failure to establish and maintain a design history file to demonstrate that the design was developed in accordance with the requirements of 21 CFR 820 as required by 21 CFR 820.30(j). Specifically, the design history file for the InTone™ medical device does not contain or reference the records necessary to demonstrate that the design was developed in accordance with an approved design plan and the quality system requirements. The first shipment of InTone™ medical device products occurred on March 12, 2012; however, work instructions for the build of the InTone™ medical device were not approved until June 21, 2012, and design control procedures were not defined and documented until July 23, 2012.
4. Failure to establish adequate procedures for design validation, which is required by 21 CFR 820.30(g). Specifically, documented evidence of design validation for the InTone™ medical device does not exist. Documentation and/or approvals are lacking for:
A. Validation being performed under defined operating conditions on initial production units, lots, or batches or their equivalents;
B. Evidence to support that the InTone™ medical device conforms to defined user needs and intended uses, and for evidence of testing of production units under actual or simulated use conditions;
C. Software validation for the control unit used with the stimulation unit;
D. Risk analysis; and
E. Results of the validation, including identification of the design, method(s), the date, and the individual(s) performing the validation.
5. Failure to maintain an adequate device master record as required by 21 CFR 820.181. Specifically, a device master record does not exist for the InTone™ medical device.
6. Failure to maintain device history records to demonstrate that the device was manufactured in accordance with the device master record and 21 CFR 820, which is required by 21 CFR 820.184. Specifically, the device history record lacks:
A. Acceptance records demonstrating the device was manufactured in accordance with the device master record;
B. The primary identification label and labeling; and
C. The device identification and control number(s) used on the outside packaging, which links the stimulator unit and the control unit that was sold to the customer.
7. Failure to document and approve process validation activities and results as required by 21 CFR 820.75(a). Specifically, a process validation does not exist for the manufacturing of the InTone™ medical device; and the results of certain aspects of the manufacturing process cannot be fully verified by subsequent inspection and test.
8. Failure to establish adequate procedures for training and identifying training needs, which is required by 21 CFR 820.25(b). Specifically, training records to document that all personnel were trained on the quality system and general company requirements do not exist as required by SOP QP62-001, Training Requirements, Revision 1, as stated below.
A. Specific training for the positions of personnel who perform tasks related to complaint handling, document control, design-related activities, and production related activities do not exist.
B. There is no evidence to support that as part of their training, personnel are made aware of device defects that may occur from improper performance of their jobs.
C. There is no documented evidence that personnel who perform verification and validation activities are aware of defects and errors they may encounter.
D. The Training Requirements procedure, step (b)(4), requires job descriptions to describe the basic training requirements for each position. Job descriptions do not exist for the following personnel:
i. VP of Manufacturing;
ii. Director of Clinical Applications; and
iii. In-House Technical Solutions (which includes document control and engineering tasks).
E. The Position Specification for the title Medical Device Assembler does not describe the basic training requirements required for this position as required by SOP QP62-001, Training Requirements, Revision 1.
9. Failure to establish adequate document control procedures, which is required by 21 CFR 820.40.
A. Documents which support the firm’s quality system are not controlled and do not have a documented review and approval, e.g., the quality policy, labels and labeling, and the bill of materials.
B. Procedures reference forms that do not exist. For example, “Control of Nonconforming Material,” QP83-001, Revision 1, states “Complete a Nonconforming Material report, Form F30-001.” Form F30-001 does not exist. Completed records for nonconforming material identify the form as F40-003, Rev. 2, “Non-Conforming Material Report,” effective “7/30/12.” A documented review and approval of nonconforming material form, F40-003, does not exist.
C. The current cover page of the “InTone™ User Manual” is identified as “PN: 2006000C1_1, Draft Date: 6/15/12.” The footer of this document states, “InTone Clinician Guide (2006000C1_1).” A documented review and approval of 2006000C1_1 does not exist. The Engineering Change Order (ECO) E12-005 lists the “InTone User Manual” as 2009000C1; but this document does not exist.
D. The “Product Complaint Form,” Form F60-001, Rev. 1, currently in use is identified as being effective “07/03/12.” The form was not reviewed and approved until 7/19/12.
E. The Quality Policy posted in the production area is dated “02/10/2012.” The approval of the policy occurred as part of the Quality Manual approval on “08/06/2012.”
10. Failure to establish procedures to control environmental conditions as required by 21 CFR 820.70(c). Specifically, environmental conditions are not monitored to ensure the operating and storage conditions meet temperature requirements of 10°C to 40°C and humidity requirements of 10% to 90%, as specified in the InTone™ Clinician Guide and User Manual.
11. Failure to evaluate and select suppliers, contractors, and consultants based on their ability to meet specified requirements, which is required by 21 CFR 820.50(a)(1). Specifically, there is no documented evidence of suppliers, contractors, or consultants being evaluated and selected based on their ability to meet specified requirements, including quality requirements. The procedure “Supplier Qualification and Approval,” QP74-001, Revision 1, step (b)(4) states “Suppliers shall be evaluated on the basis of their ability to meet specified requirements….”
We reviewed your firm’s response dated September 7, 2012, to the Form 483, concerning the above-noted violations of the Quality System Regulation, 21 CFR 820. We note that your firm agreed with the observations and initiated corrective actions to address the violations. The response did not provide documentation of the corrections, and many of the corrective actions have not been completed yet. A follow-up inspection will be necessary to assess implementation and effectiveness of the 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 15 working days from the date you receive this letter, with an update on the status of the specific steps you have taken to correct the violations cited in this Warning Letter. Include an explanation of how you plan to prevent these violations, or similar violations, from occurring again. Please provide documentation of the corrective actions 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 Timothy G. Philips, Compliance Officer, at the address on this letterhead. If you have any questions about the content of this letter please contact Mr. Philips at (612) 758-7133.
During the inspection, our investigator observed that the Indications for Use stated in your Clinician Guide and User Manual may not be consistent with the 510(k)-cleared Indications for Use. It was also noted that some promotional material contained statements such as “Class II, FDA cleared.” See 21 CFR 807.97, “Misbranding by reference to premarket notification,” copy enclosed. Please address these concerns in your response to this letter.
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 the Inspectional Observations Form FDA 483 issued at the close-out 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 to bring your products into compliance.
Michael Dutcher, DVM
Enclosure: 21 CFR 807.97