Inspections, Compliance, Enforcement, and Criminal Investigations
ThyssenKrupp Access Manufacturing, LLC 3/27/12
Department of Health and Human Services
|Public Health Service|
Food and Drug Administration
550 West Jackson Blvd., 15th Floor
Chicago, Illinois 60661
March 27, 2012
RETURN RECEIPT REQUESTED
Mr. Jurrien Vander Akker
ThyssenKrupp Access Manufacturing, LLC
4001 E. 138th Street
Grandview, Missouri 64030
Dear Mr. Vander Akker:
A United States Food and Drug Administration (FDA) investigator conducted an inspection of your firm, ThyssenKrupp Access Manufacturing, LLC, located at 509 W. Front Street in Roanoke, Illinois from November 8, 2011 through November 10, 2011. The investigator determined that ThyssenKrupp Access Manufacturing (“TKAM”) functions as a manufacturer of vertical wheelchair lifts. Under Section 201(h) of the Federal Food, Drug and Cosmetic Act (the Act) [21 U.S.C. 321(h)], these products are defined as 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.
The 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 manufacturer, processing, packing, or holding 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 (CFR), Part 820.
We received a response from Mr. Kevin Brinkman, Vice President of Engineering and Quality for TKAM, dated December 2, 2011, concerning our investigator’s observations noted on the FDA-483, Inspectional Observations, which was issued to Mr. Brinkman on November 10, 2011. We address this response below, in relation to each of the noted violations. These violations include, but are not limited to, the following:
- Failure to investigate where necessary complaints involving the possible failure of a device to meet any of its specifications, as required by 21 CFR 820.198(c). For example:
Your firm did not investigate the following complaints involving the possible failure of a vertical wheelchair lift device to meet specifications; the complaints are documented as External Quality Reports (EQR):
a. EQR (b)(4), Received 11/3/11, for a complaint of a 42 mm cylinder seal leaking for Model BC/HBC, Unit-(b)(4).
b. EQR (b)(4), Received 8/25/11, for a complaint of a keyswitch coming apart for Model PCDE/HPCDE, Unit-(b)(4).
c. EQR (b)(4), Received 2/23/11, for a complaint of a ball nut failure for Model (b)(4), Unit-(b)(4).
Your firm’s procedure for product complaints, “Product Complaint Records (External Quality Reports – EQR’s)” does not address the documentation of complaint investigations or the decision not to investigate a complaint. Seven (7) out of eleven (11) EQR records reviewed during the inspection did not document EQR closure or whether an investigation was required. Three (3) out of the four (4) remaining EQR records reviewed stated that no further investigation was required without describing what type of investigation, if any, was conducted, and the EQR’s were not closed. The remaining EQR record that was reviewed reported that further investigation was not required as no safety issue has been identified; however, your firm has not established a risk assessment or documented a determination of fault conditions that could potentially result in safety issues.
We have reviewed your response and have determined that it is inadequate in that no detail was provided as to the additional procedures that will be established to help identify items that need investigation and those that do not. In addition, your response does not indicate that all investigations will be documented. This is a repeat observation from your firm’s June 2007 inspection.
- Failure to establish procedures for corrective and preventive action, as required by 21 CFR 820.100(a). For example, the procedure, “Corrective and Preventive Action (CAPA) Procedure” does not include requirements for (i) the analyzing of quality data to identify existing and potential causes of nonconforming product or other quality problems, and (ii) the verification and validation of corrective and preventive actions.
Your firm’s personnel stated during the inspection that reviews of the EQR’s are done on a (b)(4) basis and problem types are trended; however, there are no defined action limits or thresholds for indications of quality problems. Your firm does not have a procedure that describes these quality activities. Eleven (11) EQR records for vertical wheelchair lift products were reviewed during the inspection, and none of these records identified a corrective action that was taken.
We have reviewed your response and have determined that it is inadequate in that no detail was provided as to how the CAPA procedure will be updated. This is a repeat observation from your firm’s June 2007 inspection.
- Failure to establish procedures to ensure that all purchased or otherwise received product and services conform to specified requirements, as required by 21 CFR 820.50. For example, your procedure, “Purchasing Policies”, does not include requirements to ensure that:
- Requirements that must be met by the supplier, contractors, and consultants are established and maintained;
- The type and extent of control over the product, services, suppliers, contractors, and consultants is defined based on the evaluation results.
In addition to the Purchasing Policies procedure, your firm has a First Article Inspection procedure which is used to evaluate initial lots of a new supplier to ensure that design criteria are met. There is no documentation to show that the First Article Inspection procedure has been implemented.
We have reviewed your response and have determined that it is inadequate in that no detail was provided as to how the Purchasing Policies procedure will be updated, and no corrective actions were proposed regarding the failure to follow written procedures by your employees. This is a repeat observation from your firm’s June 2007 inspection.
- Failure to document evaluations of potential suppliers, as required by 21 CFR 820.50(a)(1). For example, your firm received the following components of a Class II wheelchair lift device from a supplier without a documented evaluation of the supplier:
- Drawing # (b)(4) – RELAY, CNTRL, 2 STOP B/S DOM
- Drawing # (b)(4) – HARN, PLATFORM CONTROL 42” PORCHLIFT RELAY BOX
- Drawing # (b)(4) – HRNS, KEYSWITCH WIRE, BLACK PORCH-LIFT CALL/SEND & UNIT CNTL
These components were used in the manufacturing of a vertical wheelchair lift, Drawing # (b)(4), a Class II medical device without documentation that an inspection of the initial lots of the components was conducted to show that the supplier has the ability to meet design criteria.
We have reviewed your response and have determined that it is inadequate in that no detail was provided as to how the Purchasing Policies procedure will be updated.
- Failure to adequately establish procedures for quality audits and conduct such audits to assure that the quality system is in compliance with the established quality system requirements and to determine the effectiveness of the quality system, as required by 21 CFR 820.22. For example,
- Your firm has failed to conduct and document quality audits at scheduled intervals. Your firm has not documented the performance of a quality audit since 2001.
- Your firm’s quality audit procedures do not include requirements for determining whether both quality system activities and the results of such activities comply with your quality system procedures.
We have reviewed your response and acknowledge that you indicate that you will maintain documentation of quality audits; however, the response is inadequate in that no detail was provided as to how the quality audits procedure will be updated or how documentation will be maintained. This is a repeat observation from your firm’s June 2007 and February 2002 inspections.
- Failure to adequately establish procedures for acceptance of incoming product, as required by 21 CFR 820.80(b). For example, your firm’s Receiving Inspection procedure does not include requirements to ensure that all incoming product received is verified as conforming to specified requirements. In addition, outside of your firm’s first article inspection on the initial lots received by a supplier, you do not test, inspect, or otherwise verify that incoming product conforms to specified requirements.
We have reviewed your response and have determined that it is inadequate in that no detail was provided as to the content or adequacy of the Receiving Inspection procedure that was to be re-instated or the timeframe for the re-implementation of the procedure.
- Failure to establish procedures for identifying valid statistical techniques required for establishing, controlling, and verifying the acceptability of process capability and product characteristics, as required by 21 CFR 820.250(a). For example, your firm performs (b)(4) review of the EQR (External Quality Report) database and performs (b)(4) trending of product complaint records to identify possible quality issues; these quality activities have not been established in a procedure.
We have reviewed your response and have determined that it is inadequate in that no detail was provided as to the timeframe for completion of a written procedure for statistical techniques. This is a repeat observation from your firm’s June 2007 inspection.
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 fifteen (15) working 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 corrective action 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: Carrie Ann Plucinski, Compliance Officer, Food and Drug Administration, 550 W. Jackson Blvd., 15th floor, Chicago, IL 60661. If you have any questions about the content of this letter, please contact Ms. Plucinski at 312-596-4224.
Finally, you should know that this letter is not intended to be an all-inclusive list of the violations at your facility. Based upon the nature of the CGMP violations identified at your firm and previous inspectional findings, it is apparent that ThyssenKrupp Access Manufacturing, LLC has failed to implement global corrective actions. 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 (FDA-483), issued at the closeout of the inspection may be symptomatic of serious problems in your firm’s manufacturing and quality assurance systems. FDA expects your corporate management to undertake a comprehensive and global assessment of your operations immediately to ensure that medical devices conform to FDA requirements.
Scott J. MacIntire
cc: Mr. Kevin Brinkman
Vice President of Engineering and Quality
ThyssenKrupp Access Manufacturing, LLC
509 W. Front Street
Roanoke, Illinois 61561