Department of Health and Human Services
|Public Health Service|
Food and Drug Administration
10903 New Hampshire Avenue
VIA UPS EXPRESS
March 4, 2011
AZ Instrument (Shen Zhen) Co., Ltd.
50 Mei Bao Road, Dalang Ind. Park,
Dalang, Long Hua, Baoan
Dear Ms. Chu:
During an inspection of your firm located in Guangdong, China on November 8, 2010 through November 11, 2010, investigator(s) from the United States Food and Drug Administration (FDA) determined that your firm manufactures Glucose Test Strips for various Blood Glucose Monitoring System including the (b)(4) systems. 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 are intended 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 (CGMP) requirements of the Quality System (QS) regulation found at Title 21, Code of Federal Regulations (C.F.R.), Part 820. Your response to the FDA 483 December 3, 2010, was not reviewed because it was not received within 15 business days. The response may be evaluated along with any other written material provided in response to this Warning Letter. 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.
For example: The process for (b)(4) was identified by the firm as the most critical process for the accuracy of the (b)(4); however, this process has not been fully validated to establish the process capability and reproducibility. Only an equipment qualification and (b)(4) has been performed. Specifically, the (b)(4) Installation/Operation Qualification/Validation Instruction (CDW026-00-A1) does not identify the variables affecting the (b)(4) process and does no identify how variables are to be monitored and controlled. In addition, the actions to be taken when the (b)(4) process fails to meet its performance capability or other requirements for revalidation are not defined.
2. Failure to establish and maintain adequate procedures to control product that does not conform to specified requirements, as required by 21 CFR 820.90(a).
For example: The firm’s Control Procedure of Non Conformances (CQP006-00-A7) does not establish how in-process nonconformities will be documented to facilitate trending and/or monitoring for evaluation and investigation. In addition, the firm has not defined a threshold or action limit which will result in a nonconformance investigation and potentially a Corrective and Preventive Action (CAPA) investigation. For instance, (b)(4) number of nonconformances is documented for vials of glucose test strips that fail the in-process testing. There is no further evaluation to determine the need for an investigation of the nonconformance.
You should take prompt action to correct the violation(s) addressed in this letter. Failure to promptly correct these violation(s) may result in regulatory action, which may include detaining your devices without physical examination upon entry into the United States until the corrections are completed. Section 801(a) of the Act (21 U.S.C. § 381(a)) Also, U.S. federal agencies are advised of the issuance of all 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 (15) working days from the date you receive this letter of the specific steps you have taken to correct the noted violations, including an explanation of how you plan to prevent these violation(s), or similar violation(s), from occurring again. Include documentation of the corrective action you have taken. If your planned corrections will occur over time, please include a timetable for implementation of those corrections. If corrective action cannot be completed within 15 working days, state the reason for the delay and the time within which the corrections will be completed. If the documentation is not in English, please provide a translation to facilitate our review.
Your response should be sent to:
Allen T. Wynn
Food and Drug Administration
Field Operations Branch/Office of Compliance
10903 New Hampshire
Silver Spring, MD 20993
Refer to CMS case #162012 when replying. If you have any questions about the content of this letter please contact: Ileana Elder at (301) 796-6143.
Finally, you should know that this letter is not intended to be an all-inclusive list of the violation(s) at your facility. It is your responsibility to ensure compliance with applicable laws and regulations administered by FDA. The specific violation(s) noted in this letter and in the Inspectional Observations, Form FDA 483 (FDA 483), issued at the closeout of the inspection may be symptomatic of serious problems in your firm’s manufacturing and quality assurance systems. You should investigate and determine the causes of the violation(s), and take prompt actions to correct the violation(s) and to bring your products into compliance.
Office of In Vitro Diagnostic Device
Evaluation and Safety
Center for Devices and