Inspections, Compliance, Enforcement, and Criminal Investigations

Beyond Technology Corporation Nanchang 7/19/16

  

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
JUL 19, 2016
 
VIA UNITED PARCEL SERVICE
 
Jian Fei Tang
President
Beyond Technology Corporation
West Side of Wuhua North Road
Wangchen New District
330047 Nanchang
China
 
Dear Mr. Tang:
 
During an inspection of your firm located in Nanchang, China on November 9, 2015, through November 11, 2015, an investigator from the United States Food and Drug Administration (FDA) determined that your firm manufactures teeth whitening devices and dental floss. 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 dated November 23, 2015 concerning our investigator's observations noted on the Form FDA 483 (FDA 483), List of lnspectional 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 establish and maintain procedures to prevent contamination of equipment or product by substances that could reasonably be expected to have an adverse effect on product quality, as required by 21 CFR 820.70(e). For example, the buildings used in the manufacturing process were infested by rodents. Fresh excrement was observed on the bags of raw materials and on the windowsills in the (b)(4) room.
 
We reviewed your firm's response and conclude that it is not adequate. Your firm's response did not provide a copy or summary of documentation in English.
 
2.    Failure to establish and maintain procedures to control product that does not conform to specified requirements, as required by 21 CFR 820.90(a). For example, there were no written procedures for documenting or investigating manufacturing deviations or out of specification results. Manufacturing deviations or out of specification results were not investigated, as there were no procedures or requirements for documenting these events.
 
We reviewed your firm's response and conclude that it is not adequate. Your firm's response did not provide a copy or summary of documentation in English.
 
3.    Failure to establish procedures for identifying training needs and ensure that all personnel are trained to adequately perform their assigned responsibilities, as required by 21 CFR 820.25(b). For example, there were no written training procedures to define job specific training requirements for manufacturing operators. Completed training records lack specific details of the job related trainings. No records of GMP training were provided.
 
We reviewed your firm's response and conclude that it is not adequate. Your firm's response did not provide a copy or summary of documentation in English.
 
Given the serious nature of the violations of the Act, devices 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 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 Ill 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 3540, 10903 New Hampshire Ave., Silver Spring, MD 20993. Refer to CMS case #497078 when replying. If you have any questions about the contents of this letter, please contact: Daniel Walter, Chief, Foreign Enforcement Branch, at CDRHOCWarningletterResponses@fda.hhs.gov (email) or +1 (240) 402-4020 (telephone).
 
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 lnspectional 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/
CAPT Sean M. Boyd, MPH, USPHS
Deputy Director for Regulatory Affairs
Office of Compliance
Center for Devices and
    Radiological Health
 
 
CC:
 
RENE VAN DE ZANDE
EMERGO GLOBAL REPRESENTATION, LLC
816 Congress Ave Ste 1400,
Austin, TEXAS 78701

Page Last Updated: 08/08/2016
Note: If you need help accessing information in different file formats, see Instructions for Downloading Viewers and Players.
Language Assistance Available: Español | 繁體中文 | Tiếng Việt | 한국어 | Tagalog | Русский | العربية | Kreyòl Ayisyen | Français | Polski | Português | Italiano | Deutsch | 日本語 | فارسی | English