Inspections, Compliance, Enforcement, and Criminal Investigations

Shantou Chaonan Liangying Hegao Plastic Toy Factory 11/20/14

  

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

 

WARNING LETTER
NOV 20, 2014 
 
VIA UNITED PARCEL SERVICE
 
Ms. Karen Lee
President
Elung Industrial Co., Ltd.
Suite 507, Silvercord Tower 1, 30 Canton Road
T.S.T., Kowloon, Hong Kong
China
 
DearMs. Lee:
 
During an inspection of your firm, Shantou Chaonan Liangying Plastic Toy Factory, located in Shantou, Guangdong, China,on July 14, 2014, through July 17, 2014, an investigator from the United States Food and Drug Administration (FDA) determined that your firm manufactures 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 regulation found at Title 21, Code of Federal Regulations (CFR), Part 820.
 
We received responses from Mr. Bill Chan, General Manger, dated August 4, 2014, and September 4, 2014, 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 these responses below, in relation to each of the noted violations. These violations include, but are not limited to, the following:
 
1.    Failure to ensure, where 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, your firm has not validated the (b)(4) process for manufacturing of the sterile, fluid-filled teething rings.
 
We reviewed your firm’s responses and conclude that they are not adequate. Your firm has not provided any process validation procedures or process validation summaries. In addition, there was no indication that your firm will validate the (b)(4) processes for the sterile, fluid-filled teething rings, or evaluate other manufacturing processes to determine if additional validation activities are necessary.    
 
2.    Failure to establish and maintain procedures to ensure that all purchased or otherwise received product and services conform to specified requirements, as required by 21 CFR 820.50. For example, your firm has not ensured that your supplier has met your firm’s criteria for the (b)(4) sterilization process for manufacturing sterile, fluid-filled teething rings.
 
We reviewed your firm’s responses and conclude that they are not adequate. There was no indication that your firm will ensure that the procedure for the sterilization process for the sterile, fluid-filled teething rings conforms to specified requirements, or determine if additional supplier evaluations are necessary.   
 
3.    Failure to maintain complaint files and to establish and maintain procedures for receiving, reviewing, and evaluating complaints by a formally designated unit, as required by 21 CFR 820.198. For example, your firm’s complaint handling procedure does not ensure that oral complaints are documented upon receipt and does not appear to ensure that all complaints are evaluated for MDR reportability. Additionally, twelve complaint investigations from 2012 to 2014, which were documented on complaint record form (b)(4), did not include the name/address, phone number of the complainant, the nature and details of the complaint, and a reply to the complainant.
 
We reviewed your firm’s responses and conclude that they are not adequate. Your firm updated its complaint handling procedure. However, this procedure does not appear to ensure that all complaints are evaluated for MDR reportability. Neither the “Customer Complaint Form” (b)(4) nor the “Product Problem Review and Corrective Action Request Form” (b)(4) includes evaluation for MDR reportability. Additionally, your firm did not indicate that it will conduct training or that it will retrospectively evaluate previous complaints.
 
Our inspection also revealed that your firm’s teething ring devices 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:
 
4.    Failure to develop, maintain, and implement written MDR procedures, as required by 21 CFR 803.17. For example, at the time of the inspection, your firm did not have an MDR procedure.
 
We reviewed your firm’s responses and conclude that they are not adequate. Your firm submitted an MDR Procedure. A review of the procedure was conducted.  The following issues were noted:
 
a)    Your firm’s procedure 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, there are no definitions of what your firm will consider to be a reportable event under 21 CFR Part 803. The exclusion of definitions from 21 CFR 803.3 of the terms “become aware,” “caused or contributed,” “malfunction,” and “serious injury,” and the definition of the term “reasonably suggests,” found in 21 CFR 803.20(c)(1), 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)    Your firm’s procedure does not establish internal systems that provide for a standardized review process to determine when an event meets the criteria for reporting under this part. For example, there are no instructions for how your firm will evaluate information about an event to make MDR reportability determinations in a timely manner.
 
c)    Your firm’s procedure does not establish internal systems that provide for timely transmission of complete MDRs. Specifically, the following are not addressed:
 
i.    Instructions for how to obtain and complete the FDA 3500A form; and
 
ii.    The circumstances under which your firm must submit 30 day, supplemental or follow-up, and 5 day reports and the requirements for such reports.
 
d)    Your firm’s procedure 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 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 will take 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, teething ringsmanufactured 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 responses 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. We will notify you regarding the adequacy of your firm’s responses and the need to re-inspect your firm’s facility to verify that the appropriate corrections and/or corrective actions have been made.
 
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 #439245 when replying. If you have any questions about the contents of this letter, please contact: Daniel Walter, Chief, Foreign Enforcement Branch, at (301) 796-5587 (telephone) or (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,
/S/                                                           
Steven D. Silverman
Director
Office of Compliance
Center for Devices and
     Radiological Health

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