Inspections, Compliance, Enforcement, and Criminal Investigations
Polymer Technologies Systems, Inc. 23-Apr-08
Department of Health and Human Services
Public Health Service
RETURN RECEIPT REQUESTED
April 23, 2008
Robert S. Huffstodt
President, Chief Executive Officer
Polymer Technology Systems, Inc.
7736 Zionsville Road
Indianapolis, IN 46268
Dear Mr. Huffstodt:
The Food & Drug Administration (FDA) conducted an inspection of your facility located in Indianapolis, IN on February 4-March 5, 2008. Our investigation determined that your firm manufactures the CardioChek meters, which are portable whole blood test systems used for single and/or combination chemistry analysis . Under section 201(h) of the Federal Food, Drug, and Cosmetic Act (the Act), 21 U.S.C. 321(h), these products are considered 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. You can find more information about the Act on our website at www.fda.gov.
The inspection revealed that the devices are adulterated under 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 conformance with the Current Good Manufacturing Practice (CGMP); requirements for medical devices which are set forth in the Quality System regulation, as specified in Title 21, Code of Federal Regulations (CFR), Part 820. These violations include, but are not limited to, the following:
1. Failure to implement procedures to control the design of devices to ensure that specified requirements are met as required by 21 CFR 820.30(a). Specifically, your written procedures controlling the design of the CardioChek/CardioChek PA meters from version 2.22 to 2.30 were not implemented throughout all stages of the design process. Production of the new version of meters began in September 2005 and the design changes were not approved until September 2007. In addition, design history files for the new version do not demonstrate that the devices were developed per a design plan as required by 21 CFR 820.30(j).
2. Failure to implement procedures to ensure complaints are adequately received, reviewed, and evaluated as required by 21 CFR 820.198(a). For example, your "Customer Call Record and Complaint Handling" procedure, revision 5 dated April 30, 2007 states an inquiry is any request for information regarding a product or technique not related to an alleged deficiency. Five incoming calls were misclassified by your personnel as customer inquiries rather than complaints. The calls consisted of low recovery of patient results, erratic recovery of patient results, and software problems associated with the meters. Therefore, the calls were inadequately reviewed and evaluated per your complaint procedures.
3. Failure to ensure complaints involving possible failures are adequately reviewed and evaluated to determine if investigations are necessary as required by 21 CFR 820.198(b). For example, your firm received a complaint involving low, out of tolerance recovery with your controls. As a result, three meters were returned for evaluation. However, these meters have not been evaluated as of February 2008.
4. Failure to maintain complete corrective and preventive action (CAPA) procedures to address the analysis of sources of quality data to identify existing and potential causes of nonconforming products or other quality problems as required by 21 CFR 820.100(a)(1). Specifically, not all complaints and test strips lot failures are trended as a source of quality data to identify if quality problems exist.
5. Failure to implement procedures to address verification or validation of corrective and preventive action (CAPA) procedures as required by 21 CFR 820.100(a)(4). For example, your "Corrective, Preventative Action and Continuous Improvement" procedure, revision 6 dated March 13, 2007 states in section 5.1.2 that all Corrective/Preventive Action/Continuous Improvements remain in open status until implementation is complete and effectiveness has been confirmed by an audit. There were approximately 11 corrective actions initiated due to problems associated with defective and/or incorrect placement of components onto the main circuit board used in the CardioChek meters, arid no audit was conducted to verify or validate if corrections were effective.
6. Failure to establish procedures and monitor production processes to ensure that a device conforms to its specification as required in 21 CFR 820.70(a). For example, your firm conducts a curve verification test on the strips to evaluate performance. The curve test was performed on the [redacted] and the [redacted] and there was no justification provided of your firm's decision to disregard some of the raw data and re-test portion of lots, which were found acceptable and release for distribution. In addition, there is no formal procedure for handling out of specification (outliers) test results for in-process (membrane checks) tests.
7. Failure to ensure employees are adequately trained to perform their assigned responsibilities, as required by 21 CFR 820.25(b). For example, your firm has not ensured employees responsible for handling complaints have been adequately trained as evident by employees misclassifying five calls as inquiries rather than complaints. In addition, employees engaged in evaluating and investigating CAPA have been inadequately trained as evident by employees' not conducting verification and validation activities after initiating a CAPA.
8. Failure to establish effective procedures for or to conduct quality audits, as required by 21 CFR 820.22.
This letter is not intended to be an all-inclusive list of deficiencies at your firm. It is your responsibility to assure adherence to each applicable requirement of the Act and regulations. You must also promptly initiate permanent corrective and preventative action of your quality system.
Federal agencies are advised of the issuance of all Warning Letters about medical devices so that they may take this information into account when considering the award of contracts. Additionally, no premarket submission to which the Quality System regulation deficiencies are reasonably related will be approved until the violations have been corrected. Also, no request for Certificates to Foreign Governments will be granted until the violations related to the subject devices have been corrected.
We request that you take prompt action to correct these violations. Failure to promptly correct violations may result in enforcement action being initiated by the Food and Drug Administration without further notice. The Act provides for the seizure of violative products, the assessment of civil money penalties, and for enjoining the manufacturer and/or distributor of violative products.
We acknowledge the April 11, 2008 letter, signed by Dr. Frank M. LaDuca, Chief Science and Technology Officer, requesting a meeting, with the District. Please contact Steven B. Barber, Director Of Compliance to arrange a meeting.
Please notify this office in writing within fifteen (15) working days of, your receipt of this letter, as to the specific steps you have taken to correct these violations. You should also include a detailed explanation of each step being taken to identify and make corrections to assure that similar violations will not recur. If corrective actions cannot be completed within 15 working days, please state the reason for the delay and the time frame which the corrections will be implemented. Your written reply should be directed to Mr. Barber at the above address.
Joann M. Givens
Detroit District Office