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Thai Nippon Rubber Industry Co., Ltd. MARCS-CMS 476825 —

Thai Nippon Rubber Industry Co., Ltd.

United States

Issuing Office:
Center for Devices and Radiological Health

United States


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

Public Health Service
Food and Drug Administration
 10903 New Hampshire Avenue
White Oak Building 66
Silver Spring, MD 20993


SEP 14, 2015 
Mr. Pathompong Chupayak
Operations Director
Thai Nippon Rubber Industry Co., Ltd.
789/139 Moo 1, Pinthong Industrial Estate
Nongkham Sriracha
Chonburi 20110
Dear Mr. Chupayak:
During an inspection of your firm located in Nongkham Sriracha, Chonburi, Thailand, on May 11, 2015, through May 14, 2015, an investigator from the United States Food and Drug Administration (FDA) determined that your firm manufactures condoms. 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 Mr. Tossaporn Nilkhamhang, Quality Assurance Manager and Senior Quality Management Representative, dated June 4, 2015, concerning our investigator’s observations noted on the Form FDA 483 (FDA 483), List of Inspectional Observations, which 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 ensure that where 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, as required by 21 CFR 820.75(a). For example, your firm has not validated the (b)(4) process for chemicals, additives, (b)(4) latex used in the manufacture of condoms in (b)(4)
We reviewed your firm’s response and conclude that it is not adequate. Your firm indicated that it will validate the (b)(4) process. However, your firm did not describe any corrective actions to ensure that the (b)(4) process or other manufacturing processes are validated. 
2.     Failure to ensure that when changes or process deviations occur, the manufacturer shall review and evaluate the process and perform revalidation where appropriate, as required by 21 CFR 820.75(c). For example, your firm made changes to the latex (b)(4) process line (b)(4), which included reducing the size of (b)(4); reducing the number of (b)(4); and adding intermediate (b)(4). However, your firm has not performed revalidation of the (b)(4).
We reviewed your firm’s response and conclude that it is not adequate. Your firm indicated that it will revalidate latex (b)(4). However, your firm did not describe any corrective actions to ensure that changes to the latex (b)(4) or other manufacturing processes will trigger evaluation of the need for revalidation.
3.     Failure to ensure that where environmental conditions could reasonably be expected to have an adverse effect on product quality, the manufacturer shall establish and maintain procedures to adequately control these environmental conditions, as required by 21 CFR 820.70(c). For example, the (b)(4).
We reviewed your firm’s response and conclude that it is not adequate. Your firm indicated that it will (b)(4). However, your firm did not describe any corrective actions to ensure that similar issues do not occur in the future, or evaluation of other environmental control systems to ensure they are functioning properly.  
4.     Failure to establish and maintain procedures for implementing corrective and preventive action, as required by 21 CFR 820.100(a). For example, your firm’s Corrective and Preventive Action (CAPA) procedure, (b)(4), dated April 17, 2012, does not include requirements for verifying or validating CAPAs to ensure that such actions are effective and do not adversely affect the finished device, including for CAPAs initiated to address the failure of electronic testing to identify pinholes in condoms. Additionally, the procedure does not include requirements for ensuring that information related to quality problems or nonconforming product is disseminated to those directly responsible for assuring the quality of such product or the prevention of such problems. 
The adequacy of your firm’s response cannot be determined at this time. Your firm indicated that it will revise (b)(4) to include requirements for verification/validation of corrective actions and dissemination of information. However, documentation related to the procedure and its implementation have not been provided for our review.   
Our inspection also revealed that your firm’s condoms are misbranded under section 502(t)(2) of the Act, 21 U.S.C. § 352(t)(2), in that your firm failed or refused to furnish material or information respecting the device that is required by or under section 519 of the Act, 21 U.S.C. § 360i, and 21 CFR Part 803 – Medical Device Reporting (MDR). Significant violations include, but are not limited to, the following:
5.     Failure to develop, maintain, and implement written MDR procedures, as required by 21 CFR 803.17. For example, after reviewing your firm’s MDR procedure titled “Medical Device Reporting, Post Marketing Surveillance and Vigilance System, (b)(4)”, Release 01 – Revision 04, dated April 1, 2015, the following issues were noted:  
a.  (b)(4) does not establish internal systems that provide for timely and effective identification, communication, and evaluation of events that may be subject to MDR requirements. For example, the procedure omits the definitions from 21 CFR 803.3 for the terms “become aware,” “caused or contributed,” “malfunction,” and “MDR reportable event,” and the definition for the term “reasonably suggests,” found in 21 CFR 803.20(c)(1). The exclusion of the definitions for these terms from the procedure may lead your firm to make an incorrect reportability decision when evaluating a complaint that may meet the criteria for reporting under 21 CFR 803.50(a).
b.  (b)(4) does not establish internal systems that provide for a standardized review process to determine when an event meets the criteria for reporting under 21 CFR 803. For example:
i.  There are no instructions for conducting a complete investigation of each event and evaluating the cause of the event; and
ii.  Although the procedureincludes instructions for how your firm will evaluate information about an event to determine MDR reportability, it fails to include instructions for making determinations in a timely manner.
c.  (b)(4) does not establish internal systems that provide for timely transmission of complete MDRs.  Specifically, the following are not addressed:
i.  The circumstances under which your firm must submit initial 30 day, supplemental or follow-up, and 5 day reports and the requirements for such reports;
ii.  Page 3 of the procedure refers to 10-day reporting. This reporting timeframe is not consistent with the reporting timeframes for manufacturer reports defined in the MDR regulation and should be removed. The mandatory reporting timeframes and other information about the requirements for manufacturers can be found in 21 CFR Part 803 “Medical Device Reporting” Subpart E, located on the FDA website at: http://www.accessdata.fda.gov/scripts/cdrh/cfdocs/cfcfr/CFRSearch.cfm?CFRPart=803; and
iii.  How your firm will submit all information reasonably known to it for each event.
d.  (b)(4) does not describe how your firm will address documentation and record-keeping requirements, including:
i.  Documentation of adverse event related information maintained as MDR event files;
ii.  Information that was evaluated to determine if an event was reportable;
iii.  Documentation of the deliberations and decision-making processes used to determine if a device-related death, serious injury, or malfunction was or was not reportable; and
iv.  Systems that ensure access to information that facilitates timely follow-up and inspection by FDA.
The adequacy of your firm’s response cannot be determined at this time. Your firm provided an action plan that included revising the MDR procedure to address the items listed in the Observation by June 30, 2015. However, documentation has not been provided for our review.
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 have taken 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.
Given the serious nature of the violations of the Act, condomsmanufactured by your firm are subject to refusal of admission under section 801(a) of the Act, 21 U.S.C. § 381(a), in that they appear to be adulterated.  As a result, FDA is taking steps to refuse entry of these devices into the United States, known as “detention without physical examination,” until these violations are corrected.  In order to remove the devices from detention, your firm should provide a written response to this Warning Letter as described below and correct the violations described in this letter.  We will notify you regarding the adequacy of your firm’s response(s) and the need to re-inspect your firm’s facility to verify that the appropriate corrections and/or corrective actions have been made.
Also, 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. 
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 actions (which must address systemic problems) 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 Inspections Support Branch, White Oak Building 66, Rm. 2622, 10903 New Hampshire Ave., Silver Spring, MD 20993. Refer to CMS case #476825 when replying. If you have any questions about the contents of this letter, please contact: Daniel Walter, Chief, Foreign Enforcement Branch, at +1 (240) 402-4020 (phone), or +1 (301) 847-8139 (fax).
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,
Jan B. Welch, MHS, MT (ASCP) SBB
Acting Director
Office of Compliance
Center for Devices and
     Radiological Health

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