Inspections, Compliance, Enforcement, and Criminal Investigations

Bioland Technology Ltd. 7/18/14

  

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 18, 2014
 
VIA UNITED PARCEL SERVICE
 
Mr. David (NMI) Lee
General Manager
Bioland Technology Ltd.
Room 11122, 11/F, Liven House
61-63 King Yip St, Kwun Tong
Kowloon, HK-NA, Hong Kong, China
 
Dear Mr. Lee:
 
During an inspection of your firm located in Longag, Chinaon 03/17/2014 through 03/20/2014, an investigator from the United States Food and Drug Administration (FDA) determined that your firm manufactures Clever Choice™ Blood Glucose Monitoring System (model G-425). 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 from Mr. Lee, General Manager dated April 3, 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 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). 
 
For example, the firm does not have records demonstrating that the (b)(4) was qualified, to cover production of the (b)(4) component used to manufacture the Clever Choice™ Blood Glucose Monitoring System (model G-425).
 
We reviewed your firm’s response and conclude that it is not adequate. Your firm provided a copy of the following records: (b)(4) Your firm fid not provide documentation that employees were trained on the new procedure. Your firm did provide evidence that qualification of the (b)(4) was completed and that the (b)(4) process as fully validated as required. However, the firm did not provide documentation that a systemic corrective action was considered to include a retrospective review of products made.
 
2.    Failure to establish and maintain process control procedures that describe any process controls necessary to ensure conformance to specifications where deviations from device specifications could occur as a result of the manufacturing process, as required by 21 CFR 820.70(a).
 
For example: the firm has not implemented item #1 of their written Work Instruction (b)(4), dated 03/27/2013 which requires that Quality Control visually and functionally examine products which have been dropped on the floor. The inspector observed an employee drop a small stack of (b)(4) components on the floor and then places those components back on the production line for further processing without any review by Quality control. Further, the firm’s production records for the Clever Choice™ Blood Glucose Monitoring System (model G-425) (b)(4) components produced on 05/09-11/2013 show that a portion of these components were nonconforming due to the presence (b)(4) and/or because inadequate amount of material was delivered to (b)(4). Additionally, on 06/14/2013 the firm carried out an inspection of (b)(4) used to produce the (b)(4) component for the Clever Choice™ Blood Glucose Monitoring System (model G-425), and found that the (b)(4) required adjustment in order to prevent the presence (b)(4).
 
We reviewed your firm’s response and conclude that it is not adequate. Your firm provided a copy of the EDS and Work process (b)(4), dated 3/26/2014 which identifies the steps to be taken when products are dropped. The firm included the training documentation. Your firm provided documentation that it identified the dropped parts and completed the necessary testing to your firm did not provide evidence that a retrospective review of all production processes to ensure they were completed as required.
 
3.    Failure to establish and maintain procedures to adequately control environmental conditions where these environmental conditions could reasonably be expected to have an adverse effect on product quality, as required by 820.70(c). 
 
For example, the firm’s written procedure for controlling Electro-Static Discharge (ESD) not adequately defined and implemented, Specifically:
 
A.    The firm has not adequately implemented requirements for handling sensitive components and Printed Circuit Boards (PCB) which are listed under the (b)(4) Work Instruction, effective 08/19/2013. For example,
 
1.    Item # 1 of this Work Instruction requires employees to wear a grounded wrist-strap when handling Printed Circuit Boards (PCB). On 03/17/2014 the inspector observed one employee was (b)(4) who was handling PCB's and was not wearing the grounded wrist-strap that was located at their workstation.
 
2.    Item #3 of this Work Instruction requires PCB's to be placed into trays designed to be ESD-safe, and this instruction prohibits PCB's from being stored in a manner which allows them to come into direct contact with one another. On 03/17/2014, the inspector observed multiple PCB's held in each of (b)(4) that were (b)(4) production (b)(4) he observed the PCB's were not held in ESD-safe trays, and the PCB's were stacked so that they were in direct contact with one another. Additionally, the inspector observed that one plastic bin containing PCB's was stacked directly on top of the other plastic bin containing PCB's, such that the bottom of the upper plastic bin was a short distance from the PCB components held in the lower plastic bin.
 
B.    There are no written requirementsfor maintainingsensitive electronic componentsand/or PrintedCircuit Boards (PCB) while they are stored in the firm’s component warehouse in order to ensure against damage to those device components which may be causedby electro static discharge (ESD). On 03/17/2014, the inspector observed integrated circuit components held on plastic spools, inside cardboard boxes, on the shelvesof the firms component warehouse, and he observed only a portionof those spoolsof sensitive components were contained within ESD shielding bags.
 
We reviewed your firm’s response and conclude that it is not adequate. Your firm provided a copy of the training records and the ESD and Work Process (b)(4). The ESD and Work Process (b)(4) instruct employees to wear ESD wrist bracelet when handling PCBA, store PCBAs in ESD trays or ESD racks and integrated circuit components be stored in ESD shielding bags when not in use.
 
However, the training of the employees occurred before the ESD and Work Process (b)(4) were finalized. Also, your firm did not provide documentation that a correction and corrective action were implemented and that a systemic corrective action was considered to include a retrospective review of products made with this material to ensure that environmental conditions were controlled as required.
 
4.  Failure to establish and maintain procedures to ensure that DHRs 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:
 
A.    The firm’s device history records covering the G-425 glucose monitor devices with Serial Numbers 4231130500000I - 4231130501500 and 42301130501501 - 4231130502500, Work Orders #AI3039 and #Al3041, do not include or refer to the primary label, the carton label, or the instructions for use.
 
B.    The firm’s In-Process Quality Inspection records covering the (b)(4) processes for the G-425 glucose monitor devices with Serial Numbers 42311305000001 - 4231130501500 and 42301130501501 - 4231130502500, Work Orders #AI3039 and #Al3041, consistently do not list the actual observations made by the Quality Control employee when verifying process specificationsand product specifications.
 
C.    The firm did not document set-up of the (b)(4) equipment for production of components used to manufacture the G-425 glucose monitoring device, and the firm did not document the periodic verification of those process parameters.
 
D.    The firm’s production in-process inspection records are not consistently completed at the time that the production process is being carried out. On 03/18/2014, the inspector observed the in-process inspection records held (b)(4) and (b)(4) were incomplete in that, although components were being actively manufactured and inspected on those production lines, the records did not list information in the following fields:
 
1.    Work Order Number
2.    (b)(4) Number
3.    Quantity to be Manufactured
4.    Production Period
5.    Production Rate
 
We reviewed your firm’s response and conclude that it is not adequate. Your firm provided the box label and user manual that is attached to the back of the QA inspection report. The firm also provided completed daily inspection reports to include the confirmation of (b)(4) setup sheet, (b)(4) setting record and production information. The firm did not provide a copy of the device history procedure to show that the required elements had been included. Training records on the new procedure were not provided. Also, the firm did not provide documentation that a correction and corrective action were implemented and that a systemic corrective action was considered to include a retrospective review of all DHRs to ensure they were completed as required.
 
Our inspection also revealed that your devices are misbranded under section 502(t)(2) of the Act 21 USC 352 (t)(2), in that your firm failed or refused to furnish material or information respecting the devices that is required by or under section 519 of the Act, 21 USC 360i, and 21 CFR Part 803 – Medical Device Reporting (MDR) Regulation. Significant deviations include, but are not limited to:
 
Failure of your firm to adequately develop, maintain and implement written MDR procedures, as required by 21 CFR 803.17(a)(2). For example, during the inspection your firm acknowledged that its MDR procedure does not establish a standardized review process for determining when an event meets the criteria for reporting under this part.
 
We reviewed your firm’s response dated April 3, 2014, and conclude that it is not adequate. After reviewing the translated section of your firm’s revised procedure Number (b)(4), the following was noted:
 
1.    (b)(4), 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:
a.    There are no instructions for conducting a complete investigation of   each event and evaluating the cause of the event.
b.    The procedure, as written does not specify who makes the decision for reporting events to FDA.
c.    There are no instructions for how the firm will evaluate information about an event to make MDR reportability determinations in a timely manner.
 
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
 
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 action (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 response(s) 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 #431934 when replyingIf you have any questions about the contents of this letter, please contact: James L. Woods at 301-796-6225or 301-847-8514.
 
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/                                                           
Alberto Gutierrez
Director
Office of In Vitro Diagnostics and
Radiological Health
Center for Devices and
      Radiological Health

Page Last Updated: 08/13/2015
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