Inspections, Compliance, Enforcement, and Criminal Investigations
ANJI ZHENGBANG MEDICAL INSTRUMENT CO, LTD 9/19/13
Department of Health and Human Services
|Public Health Service|
Food and Drug Administration
|10903 New Hampshire Avenue|
Silver Spring, MD 20993
September 19, 2013
VIA UNITED PARCEL SERVICE
Wen Qiang Guo
Anji Zheng Bang Medical Instruments Co., Ltd.
Tianhu Angping Town
Dear Mr. Guo:
During an inspection of your firm located in Anji, China,on July 1, 2013, through July 4, 2013, an investigator from the United States Food and Drug Administration (FDA) determined that your firm manufactures catheter insertion kits, blood piercing devices, and surgical forceps. 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. These violations include, but are not limited to, the following:
1. Failure to establish and maintain procedures for implementing corrective and preventive action (CAPA), as required by 21 CFR 820.100(a). For example:
a. Your firm’s procedures for corrective action (ZB-QP16) and preventive action (ZB-QP17) do not require documenting the investigation related to the nonconformance and verifying or validating that the changes or corrections made were effectively implemented.
b. Your firm’s procedures do not specify that an external auditor is qualified to open and document CAPAs. However, (b)(4) CAPA records were initiated and documented by external auditors. There was no documentation to show that information from these CAPA records was passed on to the persons responsible for conducting the investigation to determine root cause and to make necessary corrections.
c. Your firm’s procedures state that the Management Representative reviews and closes CAPA records. However, (b)(4) CAPA records were reviewed and closed by the Quality Manager.
d. For the (b)(4) CAPA records reviewed for 2011-2013, your firm did not fully document effectiveness of corrective actions. The CAPA records also did not adequately document when the corrections became effective.
2. Failure to ensure, where 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 procedures, as required by 21 CFR 820.75(a). For example, there is no documentation that process validation or revalidation activities were conducted for the following: the (b)(4) used to manufacture the blood piercing device (BPD) and 9-inch forceps device; the (b)(4) used to manufacture the catheter insertion kit device; and the (b)(4) after specification and parameter changes occurred for the BPD.
3. Failure to establish and maintain procedures to ensure that the device design is correctly translated into production specifications, as required by 21 CFR 820.30(h). For example, your firm has not established procedures necessary to transfer its customer’s design specifications into production for the BPD, 9-inch forceps, and catheter insertion kit devices.
4. Failure to establish and maintain procedures to control environmental conditions that could reasonably be expected to have an adverse effect on product quality and failure to periodically inspect environmental control systems to verify that the system is adequate and functioning properly, as required by 21 CFR 820.70(c). For example, (b)(4) results for the (b)(4) area were not documented from February 2013 through June 2013.
5. Failure to maintain a record of investigation by the formally designated unit, as required by 21 CFR 820.198(e). For example, your firm’s Customer Feedback Procedure (ZB-QP19) requires the recording of complaint information on Form ZB-QR8.2.1-02. However, (b)(4) complaints for 2011-2013, recorded on Form ZB-QR7.2-06, did not document information necessary to determine an adequate root cause and did not have complete complainant contact information.
6. Failure to establish and maintain procedures to control all documents that are required by 21 CFR 820, as required by 21 CFR 820.40. For example, your firm’s Document Control Procedure (ZB-QP01) does not require that all document changes have an approval date and an effective date for the change. Consequently, documents used to record CAPAs, the CAPA Log, complaints, the Complaint Log, and Work Instructions do not contain an approval date or an effective date by responsible management.
7. Failure to maintain device history records (DHRs) and 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 Device Master Record and the requirements of 21 CFR 820, as required by 21 CFR 820.184. For example:
a. Your firm does not have a DHR procedure.
b. The DHR for the BPD fails to include or refer to the location of the primary identification label for each production batch.
c. A production record for the 9-inch forceps was not reviewed or signed by the production inspector after a shift change.
The 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. Requests for Certificates to Foreign Governments will not be granted until the violations related to the subject devices 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 (including any systemic corrective actions) 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 Operations Branch, White Oak Building 66, Rm. 2609, 10903 New Hampshire Ave., Silver Spring,
MD 20993. Refer to CMS case #409682 when replying. If you have any questions about the contents of this letter, please contact Carl Fischer at 301-796-5770 or 301-847-8137 (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.
Steven D. Silverman
Office of Compliance
Center for Devices and