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U.S. Department of Health and Human Services

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Enforcement Actions

AYGUN CERRAHI ALETIER A.S.SURGICAL INSTRUMENTS CO. 6/27/13

  

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

Public Health Service
Food and Drug Administration
 10903 New Hampshire Avenue
Silver Spring, MD 20993-0002 

 

June 27, 2013
 WARNING LETTER
 
 
VIA UNITED PARCEL SERVICE
 
Mr. Mehmet Aygun
Director
Aygun Cerrahi Aletler A.S. Surgical Instruments Co., Inc
55330 Kutlukent
Organize Sanayi Bolgesi
Samsun, Turkey
 
Dear Mr. Aygun:
 
During an inspection of your firm located in Samsun, Turkey, on April 15, 2013, through April 18, 2013, an investigator from the United States Food and Drug Administration (FDA) determined that your firm manufactures sterile container systems.  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 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.  We received a response from you dated May 3, 2013, concerning our investigator’s observations noted on the Form FDA 483 (FDA 483), List of Inspectional Observations, that was issued to your firm. 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 and maintain procedures to ensure that the device design is correctly translated into production specifications, as required by 21 CFR 820.30(h). For example, your firm’s “Designs Development Procedure (PR_006, Revision 00, dated January 1, 2012)” and “Design Planning Form (PR_006_001)” did not describe the requirements for ensuring that the device design is correctly translated into production specifications. Upon request by the FDA investigator, your firm could not produce evidence that verified the design specifications, found in document #608, were appropriately transferred into production.  
 
We reviewed your firm’s response and conclude that it is not adequate. Your firm did not provide any evidence of the actions it has taken or will be taking to correct this issue.  Rather, your firm’s response stated that it would complete the corrective actions by June 18, 2013, and send the evidence to FDA.
 
2.    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 procedure, as required by 21 CFR 820.75(a). For example, upon request by the FDA investigator, your firm could not provide evidence to verify that the (b)(4), which is used to (b)(4), was validated prior to use. Your firm’s Quality Assurance Manager stated that there is no record that a validation study was conducted on the (b)(4).
 
We reviewed your firm’s response and conclude that it is not adequate. Your firm did not provide any evidence of the actions it has taken or will be taking to correct this issue.  Rather, your firm’s response stated that it would complete the corrective actions by June 18, 2013, and send the evidence to FDA.
 
3.    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).  For example, your firm’s Design Control Procedure (PR_006, Revision 00, dated January 1, 2012) does not contain a requirement that a design change be identified; documented; validated or where appropriate verified; reviewed and approved prior to implementation. PR_006 also does not include criteria explaining what types of changes to the device would be considered design changes.
 
We reviewed your firm’s response and conclude that it is not adequate. Your firm did not provide any evidence of the actions it has taken or will be taking to correct this issue. Rather, your firm’s response stated that it would complete the corrective actions by June 18, 2013, and send the evidence to FDA.
 
4.    Failure to document all activities required under this section, and their results, as required by 21 CFR 820.100(b). For example, a review of Corrective and
 
Preventive Action (CAPA) records from 2010-2013 found that required information was not documented in multiple CAPA records. Specifically:
 
A.   The record for CAPA #205 did not include documentation of the investigation, corrective action taken (i.e., change of production process), and results of the corrective action.
 
B.   The record for CAPA #2010 did not include documentation of the investigation and corrective action taken (i.e., re-train production employees).
 
C.   The record for CAPA #215 did not include documentation of the investigation and corrective action taken (i.e., engineering change order).
 
We reviewed your firm’s response and conclude that it is not adequate. Your firm did not provide any evidence of the actions it has taken or will be taking to correct this issue.  Rather, your firm’s response stated that it would complete the corrective actions by June 18, 2013, and send the evidence to FDA.
 
5.    Failure to establish and maintain procedures for changes to a specification, method, process, or procedure, as required by 21 CFR 820.70(b). For example, your firm does not have a procedure that describes the process for documenting changes in test methods. A review of your firm’s Work Instruction TA-280, dated January 1, 2012, found that it was revised to include a (b)(4) production process. The revision was made because (b)(4). However, there was no record that the change made to the production process was verified to ensure the change did not affect the finished product, prior to implementation.
 
We reviewed your firm’s response and conclude that it is not adequate. Your firm did not provide any evidence of the actions it has taken or will be taking to correct this issue.  Rather, your firm’s response stated that it would complete the corrective actions by June 18, 2013, and send the evidence to FDA.
 
6.    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 this part, as required by 21 CFR 820.184. For example:

A.   Your firm does not have a procedure to ensure that DHRs for each lot of the Sterile Container System are maintained to show that the device is manufactured in accordance with the DMR. Upon request by the FDA investigator, your firm’s Quality Assurance Manager stated that your firm does not have a DHR procedure.

B.   DHRs for lots (b)(4) and (b)(4) of Sterilization Wrap Containers were reviewed during the inspection. Both DHRs did not contain the following:

i.      Acceptance records demonstrating that devices were manufactured in accordance with the DMR; and
ii.    The primary identification label and labeling used for each production unit.
 
We reviewed your firm’s response and conclude that it is not adequate. Your firm did not provide any evidence of the actions it has taken or will be taking to correct this issue.  Rather, your firm’s response stated that it would complete the corrective actions by June 18, 2013, and send the evidence to FDA.
 
7.    Failure to maintain device master records (DMRs) and to ensure that each DMR is prepared and approved in accordance with 21 CFR 820.40, as required by 21 CFR 820.181. For example, your firm’s DMR for the Sterile Container System does not include, or refer to the location of, the following information:
 
A.   Production process specifications including the appropriate equipment specifications, production methods, production procedures, and production environment specifications;
 
B.   Quality assurance procedures and specifications including acceptance criteria and the quality assurance equipment to be used;
 
C.   Packaging and labeling specifications, including methods and processes used; and
 
D.   Installation, maintenance, and servicing procedures and methods.
 
We reviewed your firm’s response and conclude that it is not adequate. Your firm did not provide any evidence of the actions it has taken or will be taking to correct this issue.  Rather, your firm’s response stated that it would complete the corrective actions by June 18, 2013, and send the evidence to FDA.
 
8.    Failure to establish and maintain procedures to control all documents that are required by this part, as required by 21 CFR 820.40. For example, during the inspection, the FDA investigator observed that your firm was using outdated procedures, a procedure that did not reference the current maintenance logs being used in production, and a procedure that did not reference the current version. Specifically:
 
A.   After the Production Management Procedure (PR_011) was changed to Revision 03 on March 11, 2013, your firm was observed to still be using the out of date Production Management Procedure PR_011, Revision 01, dated September 11, 2012.
 
B.   After the Final Inspection Procedure (PR_018) was changed to Revision 01 on March 11, 2013, your firm was observed to still be using the out of date Final Inspection Procedure (PR_018), Revision 00, dated January 1, 2012. Also, the procedure that your firm was observed to be using, PR_018, Revision 00, does not make reference to the document currently being used for final inspection of finished devices, Final Shipment Release Form F_017_04.
 
C.   The Maintenance Log Procedure (PR_007, Revision 1, dated September 3, 2012) requires that Form PR_007_F01 (Bakim Takp Karti, Revision 1, dated September 3, 2012) be used as the record for maintenance of production equipment. However, form PR_005_F02 (Revision 1, dated September 3, 2013) was observed being used as the maintenance log for the hydraulic press #1 and the vibrating smoothing machine.
 
D.   Your firm’s Stocking, Packaging, and Shipment Procedure PR_017, Revision 02, dated April 11, 2013, includes the addition of document PR_0174_04, Final Shipment Release Form. However, a description of how or when PR_0174_04 should be used is not referenced in PR_017. Also, pages 1 and 2 of PR_017, Revision 02, are noted as Revision 01.
 
We reviewed your firm’s response and conclude that it is not adequate. Your firm did not provide any evidence of the actions it has taken or will be taking to correct this issue.  Rather, your firm’s response stated that it would complete the corrective actions by June 18, 2013, and send the evidence to FDA.
 
U.S. 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 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.
 
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, including 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 action (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.  Please provide a translation of documentation not in English to facilitate our review.
 
Your firm’s response should be sent to: Food and Drug Administration, Center for Devices and Radiological Health, Office of Compliance, Field Operations Branch, White Oak Building 66, Rm 2609, 10903 New Hampshire Ave., Silver Spring, MD 20993. Refer to CMS case #405746 when replying. If you have any questions about the contents of this letter, please contact Carl Fischer, Ph.D. at 301-796-5770.
 
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/                                                           
Steven D. Silverman
Director
Office of Compliance
Center for Devices and
     Radiological Health
 
CC:
Dagamar Maeser
1350 Avenue of the Americas
2nd Floor
New York, New York 10019