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U.S. Department of Health and Human Services

Inspections, Compliance, Enforcement, and Criminal Investigations

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Royal King Infant Products Co., Ltd. 7/26/12

  

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 

 

 
WARNING LETTER
 JUL 26, 2012
 
 
VIA UNITED PARCEL SERVICE
 
Mr. Anant Sachdev
Chief Executive Officer
Royal King Infant Products Co., Ltd.
73/4 Moo 1, Khaelie, Krathumbaen
Samutsakhon, Thailand 
 
Dear Mr. Sachdev:
 
During an inspection of your firm located in Samutsakhon, Thailand, on April 30, 2012, through May 03, 2012, an investigator from the United States Food and Drug Administration (FDA) determined that your firm manufactures fluid-filled teething rings.  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 (QS) regulation found at Title 21, Code of Federal Regulations (CFR), Part 820.  We received a response from Mr. Narayanasamy Ramiahnaidu, Quality Manager, dated May 14, 2012, 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 adequately ensure, 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 procedures, as required by 21 CFR 820.75(a).
 
For example, during the inspection, your firm stated that it has not validated the (b)(4) process and the (b)(4) process.
 
The adequacy of your firm’s response cannot be determined at this time. Your firm noted that it is working with (b)(4), to validate the (b)(4) process in (b)(4).  Your firm is also working to validate the (b)(4) process in (b)(4). At this time, we lack evidence of this validation. In addition, your firm has not included a plan or evidence of a systemic corrective action, including review of other processes to determine if process validation is necessary.  
 
2.    Failure to establish and maintain adequate procedures for implementing corrective and preventive action, as required by 21 CFR 820.100(a).
 
For example, your firm’s procedure, “Corrective and Preventive Action,” (b)(4), Rev. (b)(4), dated (b)(4), does not include a requirement for verifying or validating the corrective and preventive action to ensure that the action is effective and does not adversely affect the finished device.  Additionally, none of the (b)(4) Corrective Action Requests (CARs) reviewed during the inspection (example: (b)(4), (b)(4), (b)(4) and (b)(4)) include evidence of verification or validation of the corrective or preventive action prior to implementation.
 
The adequacy of your firm’s response cannot be determined at this time. Your firm noted that it is currently revising the “Corrective and Preventive Action” procedure, (b)(4), that the revised procedure will be provided to FDA in (b)(4), and that your firm will prepare documents as per the revised procedure.  In addition, your firm noted that future corrective and preventive action will be reviewed for effectiveness. However, your firm has not provided evidence of implementation of the corrective action, including the copy of the revised procedure and retroactive revision of previous CARs using the revised procedure. In addition, your firm has not provided a plan or evidence of the preventive action, including training records on the new procedure.
 
3.    Failure to establish and maintain procedures for receiving, reviewing, and evaluating complaints by a formally designated unit, as required by 21 CFR 820.198(a).
 
For example, your firm stated that no procedures have been established to address receiving, reviewing, and evaluating complaints.
 
The adequacy of your firm’s response cannot be determined at this time. Your firm noted that it has created procedure (b)(4), dated (b)(4), to address receiving, reviewing, and evaluating complaints.  Your firm also noted that it will apply this procedure for all future complaints.  However, no evidence of implementation of the preventive action, including staff training on the new procedure, has been provided to FDA.  In addition, your firm has not provided evidence that previous complaints were retroactively reviewed using the newly-created procedure.
 
4.    Failure to establish and maintain procedures to ensure that complaints are evaluated to determine whether a complaint represents an event that is required to be reported to FDA under part 803, Medical Device Reporting, as required by 21 CFR 820.198(a)(3).
 
For example, your firm does not have a procedure to ensure that all complaints are evaluated to determine whether the complaints should be filed as a Medical Device Report (MDR).  In addition, your firm stated that it has never filed a MDR, nor has it reviewed complaints for MDRs.
 
The adequacy of your firm’s response cannot be determined at this time. Your firm noted that it has created procedure (b)(4), section, (b)(4), dated (b)(4), to address the evaluation of complaints to determine whether they need to be reported as MDRs.  Your firm also noted that it will apply this procedure for all future complaints.  However, no evidence of implementation of the preventive action, including staff training on the new procedure, has been provided to FDA.  In addition, your firm has not provided evidence that previous complaints were retroactively reviewed using the newly-created procedure.
 
5.    Failure to establish and maintain adequate procedures to ensure that the design requirements relating to a device are appropriate and address the intended use of the device, including the needs of the user and patient, as required by 21 CFR 820.30(c).
 
For example, your firm’s design procedure, “Design and Development,” (b)(4), Rev. (b)(4), dated (b)(4), states that the Project Manager and/or R&D will prepare a project file outlining product features, performance requirements, test methods, and acceptance requirements. However, the Design History File reviewed for the “(b)(4)” did not include this documentation and your firm stated that this documentation is not kept.
 
The adequacy of your firm’s response cannot be determined at this time. Your firm noted that it is currently revising the design procedure, “Design and Development,” (b)(4), and that it will provide the revised procedure to FDA in (b)(4). However, your firm has not provided evidence of implementation of the corrective action, including the copy of the revised procedure.  In addition, your firm has not provided a plan or evidence of the preventive action, including training records on the new procedure.
 
6.    Failure to establish and maintain procedures for verifying the device design to confirm that the design output meets the design input requirements, as required by 21 CFR 820.30(f).
 
For example, your firm’s design procedure, “Design and Development,” (b)(4), Rev. (b)(4), dated (b)(4), states that design verification is conducted (b)(4).  However, the Design History File reviewed for the (b)(4) did not include evidence that design verification had been completed.
 
The adequacy of your firm’s response cannot be determined at this time. Your firm noted that it is currently revising the design procedure, “Design and Development,” (b)(4), and that it will provide the revised procedure to FDA in (b)(4). However, your firm has not provided evidence of implementation of the corrective action, including the copy of the revised procedure.  In addition, your firm has not provided a plan or evidence of the preventive action, including training records on the new procedure.
 
7.    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 design procedure, “Design and Development,” (b)(4), Rev. (b)(4), dated (b)(4), does not address design transfer and your firm stated that no procedure exists that addresses design transfer.
 
The adequacy of your firm’s response cannot be determined at this time. Your firm noted that it is currently revising the design procedure, “Design and Development,” (b)(4), and that it will provide the revised procedure to FDA in (b)(4). However, your firm has not provided evidence of implementation of the corrective action, including the copy of the revised procedure. In addition, your firm has not provided a plan or evidence of the preventive action, including training records on the new procedure.
 
8.    Failure to establish and maintain procedures to ensure that formal documented reviews of the design results are planned and conducted at appropriate stages of the device’s design development, as required by 21 CFR 820.30(e).
 
For example, your firm’s design procedure, “Design and Development,” (b)(4), Rev. (b)(4), dated (b)(4), states that, once the first quality samples have been tested, the Project Manager and/or R&D will review the design to verify its capability to meet requirements. However, the Design History File reviewed for the “(b)(4)” did not include documentation of any design reviews.  In addition, the design procedure, “Design and Development,” (b)(4), does not ensure that participants at each design review include representatives of all functions concerned with the design stage being reviewed and an individual who does not have direct responsibility for the design stage being reviewed
 
The adequacy of your firm’s response cannot be determined at this time. Your firm noted that it is currently revising the design procedure, “Design and Development,” (b)(4), and that it will provide the revised procedure to FDA in (b)(4). However, your firm has not provided evidence of implementation of the corrective action, including the copy of the revised procedure.  In addition, your firm has not provided a plan or evidence of the preventive action, including training records on the new procedure.
 
9.    Failure to establish and maintain adequate procedures to control product that does not conform to specified requirements, as required by 21 CFR 820.90(a).
 
For example, your firm’s procedure, “Control of Non-conforming Products,” (b)(4), Rev. (b)(4), dated (b)(4), addresses identification/segregation and disposition of non-conforming products and states that it is used to control non-conformances related to raw materials, work-in-progress, and final products.  However, the procedure does not address the documentation or evaluation of non-conforming products.  Your firm stated that the process is only used to document corrective actions related to the molds and that it does not control non-conformances found with raw materials, work-in-progress, and final products.
 
The adequacy of your firm’s response cannot be determined at this time. Your firm noted that it is currently revising the “Control of Non-conforming Products” procedure, (b)(4), to address evaluating non-conforming products and that it will be provided to FDA in (b)(4).  However, your firm has not provided evidence of implementation of the corrective action, including the copy of the revised procedure.  Also, your firm has not performed a retroactive review of non-conformances found with raw materials, work-in-progress, and final products.  In addition, your firm has not provided a plan or evidence of the preventive action and systemic corrective action, including training records on the new procedure and review of other procedures for adequacy.
 
10.    Failure to establish and maintain procedures to ensure that the 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, as required by 21 CFR 820.184.
 
For example, your firm stated that it does not have a written DHR procedure. 
 
The adequacy of your firm’s response cannot be determined at this time. Your firm noted that it will create a procedure to address DHRs in order to make sure that all batch and lot records are maintained. Your firm has not provided evidence of implementation of the corrective and preventive action, including staff training on the new procedure.  In addition, your firm has not provided evidence that previous DHRs were retroactively reviewed.
                 
11.    Failure to maintain device master records (DMRs), as required by 21 CFR 820.181.
 
For example, your firm stated that it does not have DMRs for the fluid‑filled teething products.
 
The adequacy of your firm’s response cannot be determined at this time. Your firm noted that it will prepare DMRs for all U.S.-distributed teethers, and provide the DMRs to FDA in (b)(4).  However, your firm has not provided any evidence of implementation of the corrective action, including the copies of the DMRs for all US distributed teethers.
 
Given the serious nature of the violations of the Act, fluid-filled teething rings 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, 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 if your firm’s response appears to be adequate, and we may 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.  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 you have 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 (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 action 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 # 315618 when replying. If you have any questions about the contents of this letter, please contact: Cesar A. Perez, Acting Branch Chief, Dental, ENT, and Ophthalmic Device Branch at 301-796-5770, or cesar.perez@fda.hhs.gov.
 
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, 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 to bring the products into compliance. 
 
 
Sincerely yours,
/S/                                               
Steven D. Silverman
Director
Office of Compliance
Center for Device and
    Radiological Health
 
 
cc:
Mr. Mitchell Melamed, U.S. Agent
Carnival Consumer Products
1845 East 7th Street
Brooklyn, New York 11223