Inspections, Compliance, Enforcement, and Criminal Investigations

Marel Corporation 8/11/14


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

Public Health Service
Food and Drug Administration
New England District Office
One Montvale Avenue, 4th floor
Stoneham, MA 02180
Phone 781.587.7500
Fax 781.587.7556
CMS 436485
August 11, 2014
Keith D. Rice
Marel Corporation
5 Sawmill Road
West Haven, CT 06516-4111
Dear Mr. Rice:
During an inspection of your facility Marel Corporation located in 5 Sawmill Road, West Haven, CT on May 30 through June 24, 2014, an investigator from the United States Food and Drug Administration (FDA) determined that your firm is a repackager/relabeler for sterile towel/drapes. 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 to affect the structure or any 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 requirements of the Quality System Regulation found at Title 21, Code of Federal Regulations (CFR), Parts 820.
We received your response dated July 3, 2014. This was a response to the observations noted on Form FDA 483, List of Inspectional Observations that was issued to you at the close of our inspection. We address your responses below, in relation to each of the noted violations.  These violations include, but are not limited to, the following:
1.    Failure to validate with a high degree of assurance, a process whose results cannot be fully verified by subsequent inspection and test, as required by 21 CFR 820.75(a). For example:
  • Your firm did not have any validation documentation to demonstrate that your current ETO sterilization process does not adversely affect the finished device packaging.   Also, we are not aware that you are performing any testing of the finished package after sterilization to assure the integrity of your sterile finished products. (1A and 1B)
  • Your firm’s pre-sterilization packaging validation is not adequate. Your procedure, “Packaging Machine Validation, revision date 5/08” did not specify the packaging to be validated or the machinery used. The 1997 pre-sterile packaging validation data presented to our investigators during the inspection did not identify the packaging material used. (1C)
  • Your firm’s procedure, “Packaging Machine Validation, revision date 5/08”, was not complete. The test method specified in the packaging validation, TM-5 Peel Test of Package Seals, Paper-to-Paper Packages was missing page 3 of 3 and did not specify any acceptance criteria for acceptable seals. (1D)
2.    Failure to establish and maintain procedures for monitoring and control of process parameters for validated processes to ensure that the specified requirements continue to be met as required by 21 CFR 820.75 (b). For example, your firm did not perform (b)(4) requalification assessments of your ETO sterilization process.   Your “Final Report #10209044” states that the routine employed cycle should have requalification assessment performed (b)(4). The last validation of this process was performed in 2010.(1F)
We find that your July 3, 2014 response does not adequately address these deficiencies. You will need to provide documentation when all necessary validations have been completed.
3.    Failure to control and monitor production processes to ensure that a device conforms to its specifications as required by 21 CFR 820.70(a). Specifically, on June 24, 2014, our investigators observed lot 4876 (Select 215-18” X 26” Blue/White Plain Drape) being packaged and sealed on (b)(4) at (b)(4) degrees F. This temperature is 30 degrees outside your operating parameters ((b)(4)) and 20 degrees above your maximum validated temperature parameter ((b)(4)). Your current procedures do not require documentation of temperatures of the (b)(4) machine.
We find that your July 3, 2014 response does not adequately address these deficiencies. Please provide us with your current packaging parameters and supporting evidence that they are suitable for this operation. We are enclosing laboratory worksheets for a violative sample tested by FDA.
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.  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 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 firm’s response should be sent to the New England District Office. Refer to CMS case #436485 when replying. If you have any questions about the contents of this letter, please contact: Compliance Officer Diane M. Prince at 781-587-7442.
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 yours,
Mutahar Shamsi
District Director                
New England District

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