Inspections, Compliance, Enforcement, and Criminal Investigations

Shenzhen Creative Industry Co., Ltd. 1/15/16

  

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
JAN 15, 2016
 
VIA UNITED PARCEL SERVICE
 
Jia (Alice) Wang
Managing Director
Shenzhen Creative Industry, Co., Ltd.
2F, Block 3 Nanyou Tian'an Industry Town
518054 Shenzhen
China
 
Dear Mrs. Wang:
 
During an inspection of your firm located in Shenzhen, China, on August 3, 2015, through August 6, 2015, an investigator from the United States Food and Drug Administration (FDA) determined that your firm manufactures Class II patient monitors, fetal dopplers, and oximeters. 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. Wangui Zhu, Management Representative, dated August 26, 2015, and September 2, 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 the responses below, in relation to each of the noted violations. Your firm's response dated November 11, 2015, was not reviewed because it was not received within fifteen business days of issuance of the FDA 483. This response will be evaluated along with any other written material provided in response to the violations cited in this Warning Letter. These violations include, but are not limited to, the following:
 
1.    Failure to establish and maintain adequate procedures for implementing corrective and preventive action (CAPA), as required by 21 CFR 820.100(a).
For example:
 
a.  Your firm's CAPA procedure, "Corrective and Preventive Action Procedure," (b)(4) (multiple versions reviewed), does not include:
 
i.  Adequate requirements for analyzing service records, complaints, and other quality data to identify existing and potential causes of nonconforming product or other quality problems, using appropriate statistical methodology where necessary, and
 
ii.  Ensure that CAPA activities are adequately documented.
 
b. Your firm's CAPA files (b)(4) do not have documentation of all activities, including CAPA effectiveness verification.
 
c. Your firm has not evaluated complaints or service records from 2013 to present to determine if they need to be addressed by your CAPA procedure.
 
We reviewed your firm's responses and conclude that they are not adequate. Your firm revised Document Number (b)(4) and CAPA form (b)(4) to address the above procedural deficiencies, and conducted personnel training on these revised documents. However, your firm did not provide documentation that (b)(4) have been evaluated and corrected. Also, your firm did not address the criteria for evaluating complaint and service records for initiating CAPAs. In addition, your firm did not perform a retrospective review of all CAPA files to ensure that they are complete, effective, and are in compliance with the revised procedure.
 
2.    Failure to establish and maintain adequate procedures for documenting the disposition of nonconforming product, as required by 21 CFR 820.90(b)(1).
For example:
 
a.  Your firm's "Control of Nonconforming Product Procedure," Document number (b)(4), Version 3.8, does not include requirements for ensuring that disposition of nonconforming product is documented;
 
b.  Your firm does not have documentation of the disposition of defective components involving (b)(4) patient monitors that failed final testing; and
 
c.  Your firm does not mark devices returned for repair as "nonconforming" when they are brought into the (b)(4) test area, as required by your firm's procedure (b)(4).
 
We reviewed your firm's responses and conclude that they are not adequate. Your firm revised document (b)(4) to address the above procedural deficiencies, and trained relevant personnel on the revised procedure. In addition, your firm provided photographs showing designated areas for nonconforming product, as well as labeling for identifying nonconforming products. However, your firm did not conduct a retrospective review of nonconformance records to determine if nonconforming products were released, and if nonconforming products were released, take steps to mitigate the associated risk. Also, your firm did not address the disposition of (b)(4) patient monitors that failed final testing.
 
3.    Failure to establish and maintain adequate procedures for receiving, reviewing, and evaluating complaints by a formally designated unit, as required by 21 CFR 820.198(a). For example, your firm's complaint handling procedure, "Customer Related Process Control Procedures," Document Number (b)(4) (multiple versions reviewed) and associated work instructions, "Customer Complaints Handling Work Instruction," Document Number (b)(4)(multiple versions reviewed), as well as the associated Customer Feedback/Complaint Registration Form (b)(4), do not include:
 
a.  Requirements to ensure that complaints occurring outside of the United States on devices similar to those marketed to the United States are evaluated for MDR reportability; and
 
b.  Instructions for recording the required data elements of complaints.
 
We reviewed your firm's responses and conclude that they are not adequate. Your firm revised complaint handling procedures, "Customer Related Process Control Procedures," Document Number (b)(4), "Customer Complaint Registration," Document Number (b)(4), "Complaint Information Collecting Form," Document Number (b)(4), and "Customer Complaint Investigating Form," (b)(4), to address the above procedural deficiencies. In addition, your firm conducted personnel training on these revised procedures. However, your firm did not conduct a retrospective review of complaints to ensure that they are evaluated in accordance with the revised complaint handling procedures.
 
4.    Failure to establish and maintain adequate procedures for validating the device design, as required by 21 CFR 820.30(g). For example:
 
a.  Your firm's design control procedure, "Control Procedure of Design and Development," Document Number (b)(4) (multiple revisions reviewed), do not include requirements to ensure that the design validation results, including identification of the design, method, the date, and the individual performing the validation, are adequately documented in the Design History File (DHF); and
 
b.  Your firm uses the design validation testing and design validation reports (b)(4), dated March 30, 2009, and (b)(4), dated August 29, 2008, for the Genius-15 patient monitor to support the design validation requirements for UP-7000, a similar patient monitor. However:
 
i.  Your firm has not documented justification of using the Genius-15 patient monitor to quality the design validation requirements for UP- 7000 patient monitor in the validation reports.
 
ii.  The design validation reports do not have documentation of the software version used for the units under test, and
 
iii.  The design validation reports do not have documentation of the version of (b)(4) unit used at the time of the design validation testing for the Genius-15 patient monitor.
 
We reviewed your firm's responses and conclude that they are not adequate. Your firm revised Document Number (b)(4) to address the above procedural deficiencies, and conducted personnel training on the revised procedure. In addition, your firm completed re-validation testing for (b)(4) patient monitors. However, your firm did not conduct a retrospective review of other design files to determine if the design validation activities have been adequately conducted and documented in the DHF, and implemented corrective actions as necessary.
 
5.    Failure to establish and maintain adequate procedures for verifying the device design, as required by 21 CFR 820.30(f). For example:
 
a.  Your firm's design control procedure, "Control Procedure of Design and Development," Document Number (b)(4) (multiple revisions reviewed), does not include requirements to ensure that the design verification results, including identification of the design, method, the date, and the individual performing the verification, are adequately documented in the design DHF; and
 
b.  Your firm has not documented the identification of design for (b)(4) design verification test reports for a Patient Monitor Design Project (b)(4). Specifically, there were no documentation of the units under test; the software version and the (b)(4) version used; and the versions of the modules (b)(4) used on the test unit at the time of the design verification testing.
 
We reviewed your firm's responses and conclude that they are not adequate. Your firm revised Document Number (b)(4), to address the above procedural deficiencies and revised test record forms (b)(4). Your firm also conducted personnel training on these documents. Your firm verified the design of the patient monitor UP-7000. However, your firm did not conduct a retrospective review of design files to determine if the design verification activities are adequately documented, and to identify and implement any remedial actions necessary.
 
6.    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 controls procedure, "Control Procedure of Design and Development,'' Document Number (b)(4) (multiple revisions reviewed), does not state how to address incomplete, ambiguous or conflicting requirements.
 
We reviewed your firm's responses and conclude that they are not adequate. Your firm revised Document Number (b)(4), and working instruction, "Instruction for Design Review at Product Design & Developing Stages," Document Number (b)(4), to address the above procedural deficiencies. In addition, your firm trained personnel on these revised documents. However, your firm did not conduct a retrospective review of design files to ensure that incomplete, ambiguous, or conflicting requirements are adequately addressed.
 
7.    Failure to establish and maintain adequate procedures for design review, as required by 21 CFR 820.30(e). For example:
 
a.  Your firm's design controls procedures, "Control Procedure of Design and Development," Document Number (b)(4) (multiple revisions reviewed), and associated work instruction, "Instruction for Design Review During Design and Development Stages," Document Number (b)(4), Version 1.0, do not include adequate requirements which:
 
i. Define the appropriate design stages when formal documented design reviews are required to be held; and
 
ii. 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 responsibility for the design stage being reviewed.
 
b.  Your firm's design review meeting minutes for Patient Monitor Design Project UP-7000, indicate that the design review did not involve an individual without responsibility for the design stage being reviewed. In addition, your firm does not have the documents reviewed during the design review meetings.
 
We reviewed your firm's responses and conclude that they are not adequate. Your firm revised Document Numbers (b)(4), to address the above procedural deficiencies. In addition, your firm conducted personnel training on these revised documents. However, your firm did not conduct a respective review of design files to determine if the lack of an adequate procedure lead to inadequacies in the design reviews, and to determine if corrective actions were implemented where appropriate.
 
8.    Failure to establish and maintain adequate procedures to control labeling activities, as required by 21 CFR 820.120. For example:
 
a.  Your firm's "Labeling and Language Control Procedure," Document Number (b)(4), Version 1.2, does not include adequate requirements to ensure that the:
 
i.  Labeling has been examined for accuracy by a designated individual prior to storage or use;
 
ii.  Labeling and packaging operations are controlled to prevent labeling mix-ups;
 
iii.  Release of labeling is appropriately documented; and
 
iv.  Copies of the primary identification labels are retained in the device history records (DHRs).
 
b.  Your firm has not retained the copies of the primary identification labels for two purchase orders (b)(4) in the DHR.
 
We reviewed your firm's responses and conclude that they are not adequate. Your firm established "Labelling and Packaging Control Procedure," Document Number (b)(4), to address the above procedural deficiencies. In addition, your firm conducted personnel training on the revised procedure. However, your firm did not conduct a retrospective review of DHRs to identify other labeling deficiencies, and determine corrective actions as necessary
 
Given the serious nature of the violations of the Act, the 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 response 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 3523, 10903 New Hampshire Ave., Silver Spring, MD 20993. Refer to CMS case #484188 when replying. If you have any questions about the contents of this letter, please contact: Foreign Enforcement Branch Chief at feb@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
Acting Director
Office of Compliance
Center for Devices and
Radiological Health

 

Page Last Updated: 08/11/2016
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