- Global Medical Production 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|
White Oak Building 66
Silver Spring, MD 20993
VIA UNITED PARCEL SERVICE
Global Medical Production Co., Ltd.
2nd Floor, No. 4 Building
No. 3288, West ZhougShan Road
Xiuzhou District, JiaXing City
Dear Mr. Dai,
During an inspection of your firm located in ZheJiang, China, on April 27, 2015 through April 30, 2015, an investigator from the United States Food and Drug Administration (FDA) determined that your firm manufactures laparoscopic instruments. 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 you dated May 20, 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 validate a process with a high degree of assurance and approve according to established procedures where the results of a process cannot be fully verified by subsequent inspection and test, as required by 21 CFR 820.75(a). For example:
a. Your firm's packaging validation procedure, Document 34205, Rev. 1, requires (b)(4) and (b)(4) for (b)(4) used for Tyvek packaging of sterile class II devices. However, your firm did not document (b)(4) for the (b)(4). Additionally, the (b)(4) did not establish acceptance criteria.
b. The (b)(4) used in the manufacture of laparoscopic stainless steel instruments has not been validated.
We reviewed your firm's response and conclude that it is not adequate. Your firm's response states that it plans to perform a revalidation of the (b)(4) with established criteria. However, it is not clear if your firm evaluated other manufacturing processes, to assess that adequate validation was performed. Additionally, your firm's response does not address its failure to validate its ultrasonic cleaning process.
2. Failure to establish and maintain procedures for implementing corrective and preventive action, as required by 21 CFR 820.100(a). Specifically, your firm's Corrective and Preventive Action (CAPA) procedure, Document 28501, Rev. 1, does not require the following:
a. Analysis of quality data, including processes, work operations, concessions, quality audit reports, quality records, complaints, returned product, to identify existing and potential causes of nonconforming product, or other quality problems.
b. Appropriate statistical methodology to be employed where necessary to detect recurring quality problems.
c. Verifying or validating the corrective and preventive action to ensure that such action is effective and does not adversely affect the finished device.
d. Ensuring that information related to quality problems or nonconforming product is disseminated to those directly responsible for assuring the quality of such product or the prevention of such problems.
We reviewed your firm's response and conclude that it is not adequate. Your firm's response states that the CAPA procedure was modified to include the missing elements, and is translating the procedure to English. However, your firm's response did not include plans for implementation of the procedure, nor a retrospective review of past CAPAs to ensure adequate evaluation and implementation of corrective and preventive actions.
3. Failure to establish and maintain data that clearly describe or reference the specified requirements, including quality requirements, for purchased or otherwise received product and service. Purchasing documents shall include, where possible, an agreement that the suppliers, contractors, and consultants agree to notify the manufacturer of changes in the product or service so that manufacturers may determine whether the changes may affect the quality of a finished device, as required by 21 CFR 820.50(b). For example, your firm's purchasing control procedure, Document# 27401, Rev. 1, does not:
a. Establish and maintain data that clearly describe or reference the specified requirements, including quality requirements, for purchased or otherwise received product and services.
b. Require an agreement with suppliers and contractors to notify of changes in the product or service, which may affect the quality of a finished device.
We reviewed your firm's response and conclude that it is not adequate. Your firm's response states it has modified its purchase order form, and specify that contractors agree to notify of changes in the product or service if something changed before the order is accepted. Your firm has yet to demonstrate implementation of these changes. Additionally, it is not clear if a retrospective review to ensure previous changes did not affect the quality of the finished device was performed.
4. Failure to establish and maintain procedures to ensure that formal documented reviews of the design results are planned and conducted at appropriate stages of the device's design development, to include representatives of all functions concerned with the design stage being reviewed and individuals who does not have direct responsibility for the design stage being reviewed, as well as any specialists needed, as required by 21 CFR 820.30(e). For example, your firm's design control procedure, Document# 27301, Rev. 1, does not ensure inclusion of the following in design reviews:
a. Representatives of all functions concerned with the design· stage being reviewed,
b. Individuals who do not have direct responsibility for the design stage being reviewed, and
c. Specialists, as needed.
The adequacy of your firm's response cannot be determined at this time. Your firm's response states the design control procedure was modified to include a requirement that participants at each design review include representatives of all functions concerned with the design stage being reviewed and individuals who do not have direct responsibility for the design stage being reviewed. However, your firm has not provided documentation of its implementation.
Given the serious nature of the violations of the Act, laparoscopic 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 2622, 10903 New Hampshire Ave., Silver Spring, MD 20993. Refer to CMS case# 475365 when replying. If you have any questions about the contents of this letter, please contact: Daniel Walter, Chief, Foreign Enforcement Branch, at +1 (240) 402-4020 (phone), 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 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.
Jan B. Welch, MHS, MT (ASCP) SBB
Office of Compliance
Center for Devices and