Inspections, Compliance, Enforcement, and Criminal Investigations

Madison Polymeric Engineering 4/22/15


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 456082
April 22, 2015
Mr. Walter Maguire, Jr.
Madison Polymeric Engineering
965 West Main Street
Branford, CT 06405
Dear Mr. Maguire:
During an inspection of your facility Madison Polymeric Engineering, located at 965 Main Street, Branford, CT on March 10 through 23, 2015, an investigator from the United States Food and Drug Administration (FDA) determined that your firm is a manufacturer of Class 1 and 2 medical foam and detergent and a contract manufacturer of EP-4 First Step detergent pouches for Cygnus Medical, LLC.  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), Part 820. 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 acknowledge your April 2, 2015 response to the FDA 483. We have reviewed the response and have concluded that it is inadequate. 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 establish and maintain to prevent contamination of equipment or product by substances that could reasonably be expected to have an adverse effect on product quality as required by 21 CFR 820.70 (e).   
Specifically, there are no specifications for water used as a component in the EP-4 First Step Bedside Pre-Clean Kit.   For example, a (b)(4) water filter was observed to be installed incorrectly. In addition, your firm’s management was unable to verify when the observed filter was installed or the schedule regarding the replacement of such filters.
Your response to this observation is inadequate. Your response did not include evidence of the interim steps your firm is utilizing to prevent contamination prior to installation of the new filtration system referenced.

2.    Failure to identify the action(s) needed to correct and prevent recurrence of nonconforming product and other quality problems as required by 21 CFR 820.100 (a)(3).

Specifically, your firm did not implement corrective actions after being notified on 2/24/15 of a possible contamination of the EP-4 First Step Bedside Pre-Clean Kit.  For example, you did not perform any shipping holds, quarantine of products, or take other actions related to the February 2015 notification. 
Your response to this observation is inadequate. Your response did not include evidence of corrective actions taken since being informed of the incident.
3.    Failure to ensure that all equipment used in the manufacturing process meet specified requirements and is appropriately designed, constructed, places, and installed to facilitate maintenance, adjustment, cleaning and use as required in 21 CFR 820.70(g)(1).  
Specifically, there are no established maintenance or cleaning procedures for the (b)(4) semi-automatic filling machine, used in the production of the EP-4 First Step Bedside Pre-Clean Kit. During the inspection, an employee stated that the nozzle, connection collars, couplings and hoses are not cleaned.  In addition, there are no procedures for maintaining the (b)(4) in-line water filter, and no schedule for changing the filter. The water processed through this filter is used as a component in the EP-4 First Step Bedside Pre-Clean Kit.
Your response to this observation is inadequate. Your response did not include evidence of new procedures and training referenced regarding maintenance and cleaning.
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 #456082 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,
Joseph S. Matrisciano, Jr.
Acting District Director

New England District

Page Last Updated: 11/03/2017
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