- APK Technology Co., Ltd.
- Issuing Office:
- Center for Devices and Radiological Health
| || |
Department of Health and Human Services
|Public Health Service|
Food and Drug Administration
| ||10903 New Hampshire Avenue|
Silver Spring, MD 20993
August 6, 2015
VIA UNITED PARCEL SERVICE
Mr. Xiaomao Rao
APK Technology Co., Ltd.
6th Floor, C2 Building, Industrial Park of Hengfeng
Hezhou, Xixiang, Bao’an District, Shenzhen
Dear Mr. Rao:
During an inspection of your firm located in Shenzhen, Guangdong, China, on January 26, 2015, through February 3, 2015, an investigator from the United States Food and Drug Administration (FDA) determined that your firm manufactures blood pressure cuffs 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 your response, dated February 16, 2015, concerning our investigator’s observations noted on the Form FDA 483 (FDA 483), List of Inspectional Observations, which was issued to your firm. Your firm’s response dated March 11, 2015, to the Form FDA 483 (FDA 483) was not reviewed because it was not received within fifteen business days of issuance of the FDA 483. The 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 ensure that where the results of a process cannot be fully verified by subsequent inspection and test, 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, validation activities are not documented for the (b)(4) process, the (b)(4) process, and the (b)(4) process used to manufacture oximeter components.
The adequacy of your firm’s response cannot be determined at this time. Your firm updated the process validation procedures and forms to include requirements for conducting Installation Qualification, Operational Qualification, and Performance Qualification. Your firm indicated that it will train personnel, perform concurrent validations for all processes in the Master Validation Plan, and issue validation reports by April 15, 2015. However, your firm’s response did not include documentation of these corrective actions.
2. Failure to establish and maintain a design history file (DHF) for each type of device, as required by 21 CFR 820.30(j). For example, 91 of 108 models of oximeters distributed by your firm in the U.S. since 2007 do not have a DHF. Additionally, your firm does not have DHFs for 42 models of blood pressure cuffs distributed in the U.S. since 2008.
The adequacy of your firm’s response cannot be determined at this time. Your firm updated the Design and Development Management Procedure to allow for using one DHF for multiple models. Your firm established a new procedure, “Family Classification Rules”, to justify how product models fit into product families. Your firm indicated that it will issue product family specific DHFs by June 1, 2015. However, your firm’s response did not include documentation of these corrective actions.
3. Failure to ensure that all equipment used in the manufacturing process meets specified requirements and is appropriately designed, constructed, placed, and installed to facilitate maintenance, adjustment, cleaning, and use, as required by 21 CFR 820.70(g). For example, your firm stated that no documents are available to show that the (b)(4) machines used in oximeter manufacturing were installed appropriately.
The adequacy of your firm’s response cannot be determined at this time. Your firm updated the Process Validation Procedure to require Installation Qualification and Operational Qualification for the equipment listed in the Master Validation Plan. Your firm indicated that it will conduct training and issue Installation Qualification reports by April 15, 2015. However, your firm’s response did not include documentation of these corrective actions.
4. Failure to document acceptance activities, as required by 21 CFR 820.80(e). For example, your firm does not document in-process and finished product electrical testing results to ensure oximeters met acceptance criteria.
We reviewed your firm’s response and conclude that it is not adequate. Your firm updated the Production Management Procedure and the Nonconformance Control Procedure to require documentation of electrical testing. Your firm updated the Daily Inspection Report, documenting only (b)(4). However, your firm did not perform a retrospective review of in-process and finished acceptance activities for other products to ensure released products met specified criteria.
5. Failure to establish and maintain procedures for rework, to include retesting and reevaluation of the nonconforming product after rework, to ensure that the product meets its current approved specifications, as required by 21 CFR 820.90(b)(2). For example, your firm does not document the results of retesting activities for finished product release, as required by your procedures and work instructions.
We reviewed your firm’s response and conclude that it is not adequate. Your firm updated the procedures and work instructions to require evaluation and determination of potential adverse effects. However, your firm has not analyzed the risk associated with the distribution of reworked product that does not have documented retesting results to demonstrate the reworked products met finished product specifications for release.
6. Failure to establish and maintain calibration procedures that include specific directions and limits for accuracy and precision, as required by 21 CFR 820.72(b). For example, your firm’s Calibration Management Procedure requires (b)(4) calibration. However, calibration records showed greater than (b)(4) between calibration dates for (b)(4), used to conduct in-process and finished product (b)(4), and (b)(4) used for finished product testing of oximeters.
We reviewed your firm’s response and conclude that it is not adequate. Your firm stated that it will establish a calibration plan and will set alerts if equipment is less than (b)(4) from the calibration expiration date. Your firm indicated that the calibration plan will be issued and training will be conducted by April 15, 2015. However, your firm did not perform a retrospective analysis of calibration data to determine if there is a risk that nonconforming product was released due to the use of product testing equipment that was out of calibration.
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) 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, Room 2622, 10903 New Hampshire Ave., Silver Spring, MD 20993. Refer to CMS case #460945 when replying. If you have any questions about the contents of this letter, please contact: Daniel Walter, Chief, Foreign Enforcement Branch, at +1 (301) 796-5587 or +1 (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.
Jan B. Welch, MHS, MT (ASCP) SBB
Office of Compliance
Center for Devices and