Inspections, Compliance, Enforcement, and Criminal Investigations

Health Science Products Inc 8/27/14

  

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

Public Health Service
Food and Drug Administration
 
New Orleans District
404 BNA Drive
Building 200 – Suite 500
Nashville, TN 37217
 
Telephone: (615) 366-7801
FAX:   (615) 366-7802 

 

August 27, 2014
 
WARNING LETTER NO. 2014-NOL-19
 
 
UNITED PARCEL SERVICE
Delivery Signature Requested
 
Michael A. Muscari
Senior Vice-President
Health Science Products, Inc.
1489 Hueytown Road
Hueytown, Alabama 35023-2061
 
Dear Mr. Muscari:
 
During an inspection of your firm located in Hueytown, Alabama on January 9-23, 2014, an investigator from the United States Food and Drug Administration (FDA) determined your firm manufactures Class I dental chairs and dental operative units. Under Section 201(h) of the Federal Food Drug and Cosmetic Act (the Act), 21 [United States Code (USC) 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 these devices are adulterated within the meaning of Section 501(h) of the Act [21 USC 351(h)], because 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 (CFR), Part 820. You have received Warning Letter No. 2012-NOL-11, dated January 12, 2012, and met with FDA New Orleans District employees on May 6, 2013, discussing the same issues as found during FDA’s most recent inspection on January 9-23, 2014.
 
We received a response from you via email dated February 27, 2014, concerning our investigator’s observations noted on the FDA Form FDA 483, Inspectional Observations, which was issued to you on January 23, 2014. We address this response below, in relation to each of the noted violations. These violations include, but are not limited to, the following:
  
1.    Failure to establish procedures for corrective and preventive action (CAPA) [21 CFR 820.100(a)]. 
 
We have reviewed your response and have concluded it is inadequate because the CAPA procedure you developed and provided primarily quotes the subparts of the QS regulations and does not provide specific, step by step instructions and specifications to initiate a CAPA.  The procedure does not include reporting forms or address possible outcomes for CAPA dispositions or who’s responsible for these actions. The Senior Vice President is mentioned, but his role is not fully defined.
 
2.    Failure to establish procedures for receiving, reviewing, and evaluating complaints by a formally designated unit [21 CFR 820.198(a)]. 
 
We have reviewed your response and have concluded it is inadequate because again, it contains many definitions and references to the QS regulations, but there is no follow-through specific information on how to receive, investigate, and determine the outcome of a complaint or its significance.
 
3.    Failure to establish procedures to ensure all purchased or otherwise received product and services conform to specified requirements (21 CFR 820.50). Components are purchased from suppliers who have not been qualified.
 
We have reviewed your response and have concluded it is inadequate because again, the procedure has identified many acronyms and definitions; however the supplier qualifications are not defined.  The review of purchasing records is not sufficient to determine the suitability of a supplier. Usually, a firm audits a supplier to determine their suitability.
 
4.    Failure to maintain device history records (21 CFR 820.184). These records are a requirement for each device manufactured.
 
We have reviewed your response and have concluded it is inadequate because specific instructions and records were not provided to review. The procedure is unclear to anyone reading it as to what to do or how to record specific steps in the manufacturing process.
 
5.    Failure to maintain device master records (21 CFR 820.181). Your firm failed to establish and maintain device master records for your dental operative units and chairs which includes or refers to the location of all device, quality, production and process, packaging, labeling, and installation specifications.
 
We have reviewed your response and have concluded it is inadequate because a device master record usually is standardized. It is not a form to be filled out with specifications, as they should be provided as a reference against the actual manufacturing process. Again, this procedure consists of many definitions and references instead of actual real time data.
 
6.    Failure to document and maintain acceptance activities as part of the device history record [21 CFR 820.80(e)]. Your firm failed to document all inspections, tests, or other verification activities associated with receiving, in-process, and final acceptance for the dental operative units and chairs you manufacture.
 
We have reviewed your response and have concluded it is inadequate because no information was provided for review. No procedure or records were provided to verify required data is actually determined and established.
 
Our inspection also revealed your dental chairs and dental operative unit devices are misbranded under Section 502(t)(2) of the Act, [21 USC 352(t)(2)], because your firm failed or refused to furnish material or information respecting the device which is required by or under Section 519 of the Act, [21 USC 360i], and 21 CFR 803, Medical Device Reporting (MDR) regulations. Significant deviations include, but are not limited to, the following: Failure to develop, maintain, and implement written MDR procedures, as required by 21 CFR 803.17.
 
For example: Your firm failed to develop written MDR procedures, as required by 21 CFR 803.17.
 
We reviewed your firm’s response dated February 27, 2014 and conclude that it is not adequate.
 
1.    After reviewing your firm’s MDR procedure titled “(b)(4) Medical Device Reporting Policy, Rev. A”, dated January 28, 2014, the following issues were noted: 
 
    • Your firm’s MDR procedure does not establish internal systems that provide for a standardized review process to determine when an event meets the criteria for reporting under this part. For example, there are no instructions for conducting a complete investigation of each event and evaluating the cause of the event.
 
A.    Your firm’s MDR procedure does not establish internal systems that provide for timely transmission of complete medical device reports. Specifically, the following are not addressed:
 
  • Instructions for how to obtain and complete the FDA 3500A form.
  • The procedure does not include the address for where to submit MDR reports: FDA, CDRH, Medical Device Reporting, P. O. Box 3002, Rockville, MD 20847-3002.
  • Your firm’s MDR procedure does not describe how it will address documentation and record-keeping requirements, including systems that ensure access to information that facilitates timely follow-up and inspection by FDA.
 
2.    After reviewing your firm’s MDR procedure titled “(b)(4) Medical Device Reporting Policy, Rev. A”, dated January 28, 2014, the following recommendations are noted:
 
A.    Your firm’s procedure includes references to 30 day and 5 day reports, but does not specify calendar days and work days, respectively. We recommend adding these terms to your firm’s MDR procedure.
 
B.    Your firm’s procedure includes references to baseline reports. Baseline reports are no longer required and we recommend that all references to a Baseline Report be removed from your firm’s MDR procedure (see: 73 Federal Register Notice 53686, dated September 17, 2008).
 
C.    Your firm’s procedure includes references to annual certifications. Annual certifications are no longer required and we recommend that all references to an Annual Certification be removed from your firm’s MDR procedure (see: Fourth Notice, Federal Register, dated March 20, 1997: Medical Device Reporting; Annual Certification; Final rule).
 
The eMDR Final Rule requiring manufacturers and importers to submit electronic Medical Device Reports (eMDRs) to FDA was published on February 13, 2014.  The requirements of this final rule will take effect on August 14, 2015.  If your firm is not currently submitting reports electronically, we encourage you to visit the following web link for additional information about the electronic reporting requirements: http://www.fda.gov/ForIndustry/FDAeSubmitter/ucm107903.htm
 
If your firm wishes to discuss MDR reportability criteria or to schedule further communications, it may contact the Reportability Review Team by email at ReportabilityReviewTeam@fda.hhs.gov
 
3.    Failure to develop, maintain, and implement written MDR procedures (21 CFR 803.17). Your firm failed to develop and implement written MDR procedures as the manufacturer of medical devices.
 
A follow up inspection will be required to assure corrections are adequate. We will contact you to arrange a mutually convenient establishment re-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 FDA 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 they make 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.
 
We are requesting you submit to this office on the schedule below, certification by an outside expert consultant that he/she has conducted an audit of your establishment’s manufacturing and quality assurance systems relative to the requirements of the device QS regulation (21 CFR 820). You should also submit a copy of the consultant’s report, and certification by your Chief Executive Officer (if other than yourself) that he or she has reviewed the consultant’s report and that your establishment has initiated or completed all corrections called for in the report. The initial certification of audit and corrections and subsequent certifications of updated audits and corrections (if required) should be submitted to this office by the following dates:
 
  • Initial certifications by consultant and establishment – February 1, 2015
  • Subsequent certifications – 2016 and 2017
 
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 Kari L. Batey, Compliance Officer, at the above address. If you have any questions about the content of this letter please contact Ms. Batey at (615) 366-7808 or kari.batey@fda.hhs.gov.
 
Finally, you should know this letter is not intended to be an all-inclusive list of the violations at your facility. It is your responsibility to ensure applicable laws and regulations administered by FDA. The specific violations noted in this letter and in the Inspectional Observations, Form FDA 483 issued on January 23, 2014, 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 and to bring your products into compliance.
 
Sincerely,
/S/ 
Ruth P. Dixon
Acting District Director
New Orleans District

Page Last Updated: 09/16/2014
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