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U.S. Department of Health and Human Services

Inspections, Compliance, Enforcement, and Criminal Investigations

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Innolatex SDN. BHD. 5/18/11

 
  

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

 

MAY 18, 2011

WARNING LETTER

VIA UNITED PARCEL SERVICE

Mr. Goh Miah Kiat
General Manager
lnnolatex SON. BHD.
Lot 594, Persiaran Raja Lumu
Pandamaran Industrial Estate
42000 Port Klang, Selangar Darul Ehsan
Malaysia

Dear Mr. Kiat:

During an inspection of your firm located in Port Klang, Malaysia; on January 17 through January 20, 2011, an investigator from the United States Food and Drug Administration (FDA) determined that your firm manufactures male natural Latex Condoms and Condoms with a Spermicidal Lubricant. 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 are intended 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 (CGMP) requirements of the Quality System (QS) regulation found at Title 21, Code of Federal Regulations (CFR), Part 820.

We received a response from your firm dated February 10, 2011, concerning our investigator's observations noted on the Form FDA 483, List of lnspectional Observations, that was issued to you. 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 adequately ensure that when the results of a process cannot be fully verified by subsequent inspection and test that 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).

• The performance qualification for the (b)(4) machine/protocol V-OQ-06-002 did not demonstrate the consistent (b)(4) of condoms (b)(4) of the condoms (b)(4) of the condoms can have detrimental effects on the condoms and condoms can become (b)(4) if the (b)(4) is not applied correctly.

• The (b)(4) process for (b)(4) from condoms has not been adequately validated. 

The adequacy of your firm’s response dated February 10, 2011, cannot be determined at this time. Without the re-validation documentation in hand, the FDA cannot make an assessment with respect to adequacy. Your firm re-validated the (b)(4) process, (b)(4) machine with a target date of March 31, 2011. Your firm indicated that the (b)(4) on the condoms will be checked by testing (b)(4) .  

2. Failure to analyze processes, work operations, concessions, quality audit reports, quality. records, service records, complaints, returned product, and other sources of quality data to identify existing and potential causes of nonconforming product, or other quality problems, as required by 21 CFR 820.100 (a)(1). For example, (b)(4)

• Visual and (b)(4) test record for Lot 1024LC on December 24, 2010, shows that bag 12 had 7 identified (b)(4) from the (b)(4)samples tested.

• Visual and (b)(4) test record for lot 1028LC from December 28, 2010, shows that bag 7 has 5 identified (b)(4) and 5 visually observed (b)(4)

Your firm's response dated February 10, 2011, is not adequate in that no employee training documents were provided to determine evidence of implementation of the revised procedure. Your firm provided the revised procedure for "Corrective and Preventive Action" (QP-16- Effective Date: February 9, 2011 -Revision 04) that stated the QA Manager shall issue a Corrective Action Report (FQA-19) to Production Manager/ Production Supervisor when the following situations arise:

(b)(4)

(b)(4)

Additionally, your firm's CAR form (FQA-19) was revised to include a column for for (b)(4)

3. Failure to investigate the cause of nonconformities relating to product, processes, and the quality system, as required by 21 CFR 820.100(a)(2). For example:

The procedure for Corrective and Preventive Action (QP-16 - Effective Date: February 2, 2009 - Revision 3,) does not describe that the nonconformance will be investigated to determine the cause.

On January 12, 2011, electronic testing identified a (b)(4) rejection rate of (b)(4) for condom Lot 1009LC. On January 11, 2011, electronic testing identified a (b)(4) rejection rate of (b)(4) for condom Lot 1020LB. Your firm did not establish electronic testing criteria to determine when an investigation was needed based on (b)(4) rejection rates. Neither of the two (b)(4) rejection rates was investigated to determine the cause of nonconformities.   

Your firm’s response dated February 10, 2011, is not adequate in that no employee training documents were provided to determine evidence of implementation of the revised procedures. Your firm provided the revised procedure for “Corrective and Preventive Action” (QP-16 - Effective Date: February 9, 2011 - Revision 04) that stated that the person in charge of respective areas shall review and investigate the cause of nonconformities. Your firm’s Corrective Action Report form (FQA-19) was revised to include a column for (b)(4)Your firm provided the revised Electronic Testing Record (FPD-07) to include (b)(4) and (b)(4) columns. Additionally, your firm revised the Manufacturing Plan (WPD-01 - Effective Date: February 10, 2011 - Revision 17) that stated that the supervisor will investigate the root cause for rejects more than (b)(4).
 
4.  Failure to identify action(s) needed to correct and prevent recurrence of nonconforming product and other quality problems, as required by 21 CFR 820.100(a)(3). For example, the 2010 Production Summary identified several quality indicators that did not meet your firm’s quality expectations. Specifically, the percentage of (b)(4) did not meet the expectation (< or = (b)(4)) for Line A in September (b)(4), October (b)(4), November (b)(4), and December (b)(4), 2010. Your firm did not initiate any corrective actions to address these issues.
  
This QS regulation deficiency was identified during our review of your firm’s Establishment Inspection Report that was prepared by the FDA investigator who conducted the inspection of your facility. Therefore, this QS regulation deficiency was not placed on the Form FDA 483, List of Inspectional Observations, that was issued to you at the close of the inspection.    
 
5.  Failure to document all activities required under 21 CFR 820.100(a), and their results, as required by 21 CFR 820.100(b). For example, the Corrective Action Report (CAR-08-03) describes that three condom batches were "rejected due to (b)(4) problems.”  However, the CAR-08-03 does not include a documented investigation leading to the final corrective action. Additionally, your firm’s CAR form does not include a space for documenting the investigation of the nonconformance.
 
Your firm’s response dated February 10, 2011, is not adequate in that no employee training documents were provided to determine evidence of implementation for the revised procedure. Your firm provided the revised procedure for “Corrective and Preventive Action” (QP-16 - Effective Date: February 9, 2011 - Revision 04) that stated under section 7.4, (b)(4)
 
6.  Failure to establish and maintain procedures to control the design of the device in order to ensure that specified design requirements are met, as required by 21 CFR 820.30(a). For example, your firm does not have design control procedures for the (b)(4) condom associated with your 510(k) covered under K053367. Design requirements are identified in the Quality Manual, but the manual includes the statement that (b)(4).
 
Your firm’s response dated February 10, 2011, is not adequate in that no employee training documents were provided to determine evidence of implementation for the new procedure. Your firm drafted the (b)(4) (QP-30 - Effective Date: January 26, 2011 - Revision 0). Additionally, your Quality Manual (QM - Effective Date: January 26, 2011 - Issue No. 9) was revised to delete the statement (b)(4).
 
7.  Failure to establish and maintain a design history file (DHF) for each type of device. The DHF shall contain or reference the records necessary to demonstrate that the design was developed in accordance with the approved design plan and the requirements of 21 CFR 820, as required by 21 CFR 820.30(j). For example, there is no DHF for the (b)(4) condom associated with your firm’s 510(k) covered under K053367.
 
Your firm’s response dated February 10, 2011, is not adequate. Your firm did not provide evidence of implementation of the correction and the corrective action specific to the preparation of the “Design History Files”. Your firm prepared (b)(4) for all products that are in current production with a target date of March 31, 2011.
 
8.  Failure to develop, conduct, control, and monitor production processes to ensure that a device conforms to its specifications.  Where deviations from device specifications could occur as a result of the manufacturing process, the manufacturer shall establish and maintain process control procedures that describe any process controls necessary to ensure conformance to specifications.  Where process controls are needed, they shall include monitoring and control of process parameters during production, as required by 21 CFR 820.70(a).  For example: 
 
(b)(4) 

•There were no controls to ensure that the (b)(4) testers are operating at the validated speed of (b)(4) pieces per minute.

The adequacy of your firm’s response dated February 10, 2011, cannot be determined at this time. Without the re-validation documentation in hand, the FDA cannot make an assessment with respect to adequacy. Your firm provided the revised (b)(4) (QP-25 - Effective Dated: February 10, 2011 - Revision 03) and the (b)(4) (FPD-14 - Revision 2) that included a monthly review for machine speed. Your firm will re-validate the (b)(4) with the following target dates: March 15, 2011; April 15, 2011; and May 15, 2011. Additionally, your firm adjusted the (b)(4) and will re-validate to find a range of (b)(4) with a target date of March 31, 2011. 

9. Failure to ensure that all inspection, measuring, and test equipment, including mechanical, automated, or electronic inspection and test equipment, is suitable for its intended purposes and is capable of producing valid results, as required by 21 CFR 820.72(a). For example, the (b)(4) Tested Condoms report for Lot 1020KB on November 20, 2010, shows that (b)(4) bags that were sampled had (b)(4) condoms with (b)(4) failures after 100% electronic testing. The (b)(4) Tested Condom report for Lot 1024KB on November 24, 2010, shows that (b)(4) bags that were sampled had (b)(4) condoms with (b)(4) failures after 100% electronic testing. The condoms that had been found to fail were tested by (b)(4) machine numbers (b)(4) for both November testing dates. No investigation was made to verify the performance of these machines.
 
Your firm’s response dated February 10, 2011, is not adequate in that the response did not address this QS regulation deficiency as to why no investigation was made to verify the performance of the (b)(4)
 
10. Failure to establish and maintain adequate procedures to ensure that device history records (DHR's) for each batch, lot, or unit are maintained to demonstrate that the device is manufactured in accordance with the DMR and the requirements of 21 CFR 820, as required by 21 CFR 820.184. For example, the DHR for the Lot number 0926JB did not document the following:
 
(b) (4)
 
Your firm’s response dated February 10, 2011, that is not adequate. Your firm provided no evidence of implementation to ensure both (b) (4) parameters are placed in the DHR.  Your firm revised the (b)(4) (FPD-04- Effective Date: February 10, 2011 - Revision 6) to include the (b)(4).  Your firm also revised the (b)(4)  form (FPD-09 - Effective Date: February 10, 2011 - Revision 3) to include the (b)(4).
 
Given the serious nature of the violations of the Act, the latex condoms manufactured 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 may take steps to refuse these products, known as "detention without physical examination," until these violations are corrected.  In order to remove the devices from detention, you should provide a written response to this Warning Letter as described below and correct the violations described in this letter.  We will notify you if your response is adequate, and we may need to re-inspect your facility to verify that the appropriate corrections have been made.
 
Also, U.S. federal agencies are advised of the issuance of all 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 15 working days from the date you receive this letter of the specific steps you have taken to correct the noted violations, including an explanation of how you plan to prevent these violations, or similar violations, from occurring again.  Include documentation of the corrective action you have taken.  If your planned corrections will occur over time, please include a timetable for implementation of those corrections.  If corrective action cannot be completed within 15 working days, state the reason for the delay and the time within which the corrections will be completed.  Please provide a translation of documentation not in English to facilitate our review.
 
Your response should be sent to: Field Operations Branch/DRMO/OC at the address listed on the letterhead. Refer to CMS Case #179013 when replying. If you have any questions about the content of this letter please contact: Paul F. Tilton, Chief, Ob/Gyn, Gastroenterology, and Urology Devices Branch at 301-796-5493 or (fax) 301-847-8137.
 
Finally, you should know that this letter is not intended to be an all-inclusive list of the violations at your facility.  It is your responsibility to ensure compliance with applicable laws and regulations administered by FDA.  The specific violations noted in this letter and in the Inspectional Observations, Form FDA 483 (FDA 483), issued at the closeout of the inspection may be symptomatic of serious problems in your firm’s manufacturing and quality assurance systems.  You should investigate and determine the causes of the violations, and take prompt actions to correct the violations and to bring your products into compliance. 
 
Sincerely yours,
 
/s/
 
Steven D. Silverman
Director
Office of Compliance
Center for Devices and
Radiological Health