Inspections, Compliance, Enforcement, and Criminal Investigations

Conductive Technologies, Inc 6/18/14

  

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

Public Health Service
Food and Drug Administration
 PHILADELPHIA DISTRICT
900 U.S. Customhouse
2nd and Chestnut Streets
Philadelphia, PA 19106
Telephone: 215-597-4390 

 

WARNING LETTER
14-PHI-11
 
Delivered Via United Parcel Service
 
 
June 18, 2014
 
Mr. Erwin Huber, Chairman of the Board and Owner
Conductive Technologies, Inc.
935 Borom Road
York, PA 17404-1382
 
Dear Mr. Huber:
 
During an inspection of your firm located in York, Pennsylvania, from March 4, 2014 to March 12, 2014, investigators from the United States Food and Drug Administration (FDA) determined that your firm is a contract manufacturer of GenStrip Blood Glucose Test Strips. Under section 201(h) of the Federal Food, Drug, and Cosmetic Act (the Act), 21 U.S.C. 321(h), GenStrip Blood Glucose Test Strips 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 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, their 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. The violations include, but are not limited to, the following:
 
1.   Failure of management with executive responsibility to review the suitability and effectiveness of the quality system with sufficient frequency, as required by 21 CFR 820.20(a).
 
Specifically, management with executive responsibility has not ensured that an effective quality system is implemented and maintained. For example, your firm is not consistently following the procedures outlined in your quality system manual and quality system including audits, complaint handling, design controls, corrective and preventive action, non-conformances, final acceptance, and document controls. In addition, authority and responsibility of individuals performing final QA sign off and lot release has not been defined or documented.
 
2.   Failure to adequately establish procedures for finished device acceptance, as required by 21 CFR 820.80(d).
 
Specifically,
 
(a) The "(b)(4)", is used to determine the (b)(4) code for each lot of GenStrip blood glucose test strips. Section (b)(4) of the procedure states that (b)(4) should be chosen. The code assignment for GenStrip glucose test strip (b)(4) was assigned using this procedure. When section (b)(4) of this procedure was performed on GenStrip (b)(4), the results for (b)(4) codes passed the acceptance criteria specified in this section. However, your firm did not perform the steps specified in section (b)(4) and did not (b)(4), but there is no documentation of the rationale or procedures used to choose code (b)(4).
 
(b) Your firm has not established procedures to determine if acceptance activities required by the DMR are complete, if the documentation is reviewed, and if the release is authorized by the signature of a designated individual.
 
3.   Failure to demonstrate in the design history file that the design was developed as required by 21 CFR 820.30(j).
 
Specifically,
 
(a) Your firm did not develop or document design plans that describe or reference design activities and define responsibility. 
 
(b) Your design input document entitled "(b)(4)" was not included in the design history file.
 
(c) There is no documentation that demonstrates that design output meets the design input requirements.
 
(d) Your design validation does not demonstrate that design meets user needs and is capable of performing as intended.
 
(e) There was no assurance the device design had been correctly translated into production specifications. 
 
4.   Failure to perform Risk Analysis, as required by 21 CFR 820.30(g).
 
Specifically,
 
(a) Your firm has not implemented the requirements of your "(b)(4)" in that no risk management plan has been developed for the GenStrip design project.
 
(b) Your firm did not assess the potential risk to the user when the (b)(4), which is a (b)(4) control to confirm the accuracy of the test strip, was removed from the labeling.
 
(c) Review of your "(b)(4)," which is used to document product-related quality issues within the CAPA system, does not define how the risk based decisions for "(b)(4)" were assigned. Additionally, the procedure does not identify the appropriate corrective action necessary if there is an elevated risk to the user. 
 
5.   Failure to adequately establish procedures for design change, as required by 21 CFR 820.30(i).
 
Specifically, a design change implemented on or about (b)(4) to change the (b)(4) on the (b)(4) was not documented under a Manufacturing Change Order to ensure all design and process control requirements and regulatory impact assessments had been identified and approved. In addition, your firm does not have design control change order procedures specifying when validation or, where appropriate, verification must be completed, documented, reviewed and approved before implementation of the changes.   
 
6.   Failure to adequately validate your manufacturing process, as required by 21 CFR 820.75(a)
 
Specifically, your firm used setup parameters based on a (b)(4) qualification run conducted on a different blood glucose test strip (b)(4), not the GenStrip test strip. These setup parameters were used for the (b)(4)machines. Consequently, there is no justification that these parameters are acceptable to manufacture the GenStrips which had different design requirements than the (b)(4).  Subsequently, the initial parameters were changed for released production lots that were manufactured in 2013. Additionally, there was no documentation confirming how the 2013 setup changes were made in the vertical offset for the (b)(4), and how the changes in (b)(4)for (b)(4) had been qualified.
 
7.   Failure to adequately establish procedures to control non-conforming product, as required by 21 CFR 820.90(a).
 
Specifically, review of the device history records for (b)(4) lots of GenStrip test strips (that had been segregated from finished release lots) revealed that lots were identified as "(b)(4)" due to quality-related issues. These issues were reported as "(b)(4)." None of these occurrences resulted in escalation to a non-conforming product report (NCR) for root cause investigation.
 
8.   Failure to adequately document corrective and preventative action activities (CAPA), as required by 21 CFR 820.100(b).
 
Specifically, the "(b)(4)" showed that the stability results failed to meet the referenced acceptance criteria, but the memo concludes that the results meet stability claims at (b)(4). There is no documentation of further investigation or corrective or preventative action of these results.
 
9.   Failure to meet the requirements for suppliers and contractors, as required by 21 CFR 820.50(a).
 
Specifically, a supplier agreement has not been established between your firm and:
 
(a) The (b)(4) to define quality system responsibilities such as finished device packaging and shipping. Requirements such as temperature and humidity control during transit and storage have not been defined.
 
(b) (b)(4) to define quality system responsibilities such as complaint handling and MDR reporting. 
 
10. Failure to adequately maintain complaint files, as required by 21 CFR 820.198(a).
 
Specifically, your firm did not obtain complaint information from (b)(4) until approximately (b)(4) after the complaint was received, in order to perform a review, evaluation, or investigation into the possible failure of the device, labeling, and packaging.
 
11. Failure to document in-process inspections, tests, or other verification activities and approvals, as required by 21 CFR 820.80(c).
 
Specifically, review of the (b)(4) revealed that the original verification data, dated (b)(4), was taken out of the DHR and replaced with verification data generated on (b)(4). Justification as to why these documents were removed and replaced was not documented.
 
12. Failure to adequately establish document control procedures, as required by 21 CFR 820.40.
 
Specifically,
 
(a) Your firm released trial lots as finished lots prior to approval of a manufacturing change order. For example, FDA review of manufacturing change order (b)(4) documented changes to the (b)(4) used to manufacture the GenStrips which were released to production on (b)(4). The changes were implemented prior to the MCO approval date of (b)(4). A file memo, dated (b)(4) stated lots (b)(4) were manufactured under a "(b)(4)" status due to the change in the dimensions of the (b)(4). A review of the device history record for lot (b)(4) revealed it was released on or about (b)(4), which was before the approval date of the MCO.
 
(b) Document control and quality procedures do not identify who, what, how, and when changes to a specification can be made. For example, the operator changed the (b)(4) from (b)(4). A review of the "(b)(4)" for this same lot revealed that the operator changed the (b)(4) requirement from (b)(4).
 
13. Failure to adequately establish process control procedures necessary to ensure conformance to specifications, as required by 21 CFR 820.70(a).
 
Specifically, there are no established procedures defining the frequency for monitoring the automated equipment (e.g. (b)(4) machine) used to manufacture GenStrip blood glucose test strips.
 
14. Failure to base sampling plans on valid statistical rationale, as required by 21 CFR 820.250(b).
 
Specifically, your sampling plan for "(b)(4)" is not based on a valid statistical rationale as specified in your "(b)(4)" procedure.
 
15. Failure to establish procedures for management review, as required by 21 CFR 820.20(c).
 
Specifically, your firm has no procedures for management review.
 
16. Failure to conduct internal quality audits at sufficient frequency to determine whether the quality system activities and results comply with quality system procedures, as required by 21 CFR 820.22.
 
Specifically, your "(b)(4)" states that an internal quality audit of (b)(4) of the quality system will be conducted at least (b)(4). Your "(b)(4)" does not audit (b)(4). Your Quality Systems Manager stated that these are audited every (b)(4).
 
17. Failure to adequately establish training procedures, as required by 21 CFR 820.25(b).
 
Specifically, your training procedure does not address potential device defects due to improper performance of their jobs. Additionally, key management personnel have not completed training in 21 CFR 820.
 
We received written responses from your firm, dated (b)(4), and your representations in these letters concerning your corrective actions to the observations noted on the Form FDA 483 (FDA 483), List of Inspectional Observations, that was issued to Matthew K. Musho, Ph.D., President, at the conclusion of the inspection. We recognize your attempts to achieve voluntary compliance in these letters; however your corrective actions cannot be fully evaluated at this time. They will be assessed and verified during the next inspection at your facility.
 
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. Also, 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. 
 
Please notify this office in writing within fifteen (15) business days from the date you receive this letter of the specific steps your firm has taken to correct the noted violations, as well as an explanation of how your firm plans 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 written response should be sent to Richard C. Cherry, Compliance Officer, U.S. Food and Drug Administration, 900 U.S. Customhouse, 200 Chestnut Street, Philadelphia, Pennsylvania 19106. If you have any questions about this letter, please contact Mr. Cherry at (215) 717-3075 or e-mail at Richard.Cherry@fda.hhs.gov.
 
Finally, you should know that 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 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 actions to correct the violations and bring the products into compliance. 
 
 
Sincerely,
/S/ 
Anne E. Johnson
Acting District Director
Philadelphia District
  
 
cc:       Matthew K. Musho, Ph.D., President
            Conductive Technologies, Inc.
            935 Borom Road
            York, PA 17404-1382
 
            Pennsylvania State Department of Health
            132 Kline Plaza, Suite A Harrisburg, PA 17104
            Attention: Director, Division of Primary Care and Home Health Services
 

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