Inspections, Compliance, Enforcement, and Criminal Investigations

Acme Monaco Corporation 4/28/14

  

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

 

WARNING LETTER
 
CMS 427918
 
                                                                                                           
UNITED PARCEL SERVICE
OVERNIGHT DELIVERY
 
April 28, 2014
 
Mr. Michael J. Karabin
Chief Executive Officer
Acme Monaco Corporation
75 Winchell Road
New Britain, CT 06052
 
Dear Mr. Karabin:
 
During an inspection of your firm located in New Britain, CT on February 18 through March 7, 2014, an investigator from the United States Food and Drug Administration (FDA) determined that your firm manufactures medical guidewires for cardiovascular and urologic use. 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 a response dated March 27, 2014 from Rebecca Karabin-Ahern, Executive Vice President. 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 establish and maintain design validation procedures to ensure that devices conform to defined user needs and intended uses and shall include testing of production units under actual or simulated conditions of use, as required by 21 CFR 820.30(g). Specifically, you have not validated the design of PTFE coated guidewires under actual or simulated conditions of use and your risk analysis is inadequate in that it does not assess flaking and delaminating of coating during use. 
 
We find that your March 27, 2014 response does not adequately address these deficiencies. We acknowledge that you have ceased to supply medical guidewire products that use any post-coated PTFE formula. However, it appears medical guidewires, manufactured by your firm under these violative conditions, may still be on the market and available for use by health care practitioners. Your firm should perform a risk assessment to determine whether correction or removal is necessary for the affected products. You have not provided us with design control procedures or an adequate risk analysis. In response to this Warning Letter, we will require documentation of these procedures when complete and a description of any corrective action that may be required.
 
2.    Failure to establish and maintain procedures for the identification, documentation, validation, or where appropriate, verification, review, and approval of design changes before their implementation, as required by 21 CFR 820.30(i).  Specifically, your firm lacks procedures to control changes to the device design, specifically the formulation of the PTFE coating material changed from (b)(4) PTFE (b)(4) to (b)(4) PTFE (b)(4) on 02/25/13, and to PTFE Fluoromed UB2-MA-847ZP, Green, on 08/06/13 without any evaluation of validation, verification, review or approval prior to implementation of the change.
 
We find that your March 27, 2014 response does not adequately address these deficiencies.   We acknowledge that you have ceased to supply medical guidewire products that use any post coated PTFE formula. You have not provided any documented procedures to control changes to the device design. In response to this Warning Letter, we will require documentation of these procedures when complete and a description of any corrective action that may be required.
 
3.    Failure to establish and maintain procedures for implementing corrective and preventative actions, as required by 21 CFR 100(a).  For example:
 
A.    Your firm failed to implement identified corrective actions in response to complaint # 6240 regarding PTFE coating flaking during use.  You identified the need for an acceptance test to assess coating integrity for incoming coated guide wires received from outside vendors on 8/7/13, but did not implement action prior to shipping product from lot 056066-1-1A on 8/23/13 or lot 056066-1-1B on 10/3/13. 
 
We find that your March 27, 2014 response does not adequately address these deficiencies.   We acknowledge that you have ceased to supply medical guidewire products that use any post coated PTFE formula. You stated that the unapproved draft procedure for testing Lot 056066-1-1A was finalized in a SOP update on 9/10/14. This date appears to be incorrect and you did not provide a document. You state you have amended or created SOPs to address this observation but did not provide any documentation. In response to this Warning Letter, we will require documentation of these procedures when complete and a description of any corrective action that may be required.
 
B.    You have not adequately investigated nonconforming product to identify all appropriate corrective actions. Specifically, non-conforming product was identified in existing inventory of lot 056066-1-1B on 10/22/13 after shipment of (b)(4) guide wires on 10/03/13 had already occurred.  Non-conforming material failed wet abrasion and tape tests for coating flaking and bent or bridging parts, in total 1010 out of 1680 guide wires failed testing.  The investigation of the non-conformance did not include any evaluation of, or risk assessment, to identify any health hazard associated with the (b)(4) units previously distributed from lot 056066-1-1B, which did not undergo any acceptance testing for coating integrity. 
 
We find that your March 27, 2014 response does not adequately address these deficiencies.   We acknowledge that you have ceased to supply medical guidewire products that use any post coated PTFE formula. You state that your QA Director believes the devices have already been “consumed”.   Please provide evidence that this is the case. You state that you have “a few packs” that are still in your distribution branch. Please provide a response addressing what you plan to do with these packs.   You state you updated SOP No. QA-Medical Device Risk Mgt-“Medical Devices”-Risk Management Plans” but provided no final written document. In response to this Warning Letter, we will require documentation of these procedures when complete and a description of any corrective action that may be required.
 
4.    Failure to ensure that when the results of a process cannot be fully verified by subsequent inspection and test, the process shall be validated with a high degree of assurance and approved according to established procedures, asrequired by 21 CFR 820.75(a). For example your firm has not validated the following processes:
 
A.    Cleaning of finished medical guidewires before coating using the Ultra Kool vapor immersion type solvent-based degreasing unit,
 
B.     Post-coating of guidewires you contract to outside vendors, and
 
C.     Solvent-based cleaning of pre-coated guide wires using equipment designed and built by your firm.
 
We find that your March 27, 2014 response does not adequately address these deficiencies.   We acknowledge that you have ceased to supply medical guidewire products that use any post-coated PTFE formula. You have not provided any validation documentation for the PTFE coating processes or the methods you are currently using to test the adhesion of the coating to guidewires, such as the fingernail, tape and wet abrasion tests. You have not provided documentation, such as a copy of your Final Validation Report or copies of written SOPs, for pre and post coated guidewire cleaning processes. In response to this Warning Letter, we will require documentation of these procedures when complete and a description of any corrective action that may be required.
 
5.    Failure to establish and maintain procedures to ensure that device history records (DHRs) for each batch, lot, or unit are maintained to demonstrate that the device is manufactured in accordance with the device master record (DMR) and the requirements of 21 CFR 820, as required by 21 CFR 820.184. You have not established procedures for device history records. Specifically, a sample of these records was reviewed during the inspection; 40 % (6 of 15) of the records were not properly documented, either lacking required information or containing incomplete information.
 
We find that your March 27, 2014 response does not adequately address these deficiencies. You state that you will develop a procedural checklist but did not provide the finished document. You state you will create a log and a document to be stored in the device history record but did not provide copies of these in your response. In response to this Warning Letter, we will require documentation of these procedures when complete and a description of any corrective action that may be required.
 
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 #427918 when replying. If you have any questions about the contents of this letter, please contact: 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,
/S/                                                      
Mutahar S. Shamsi
District Director
New England District

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