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U.S. Department of Health and Human Services

Inspections, Compliance, Enforcement, and Criminal Investigations

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Huaiyin Medical Instruments Co., Ltd., 11/20/09


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

NOV 20 2009



Li Datong
General Manager
Huaiyin Medical Instruments Co. LTD.
No.8 West Mingyuan Road
Huaian 223003, China

Dear Mr. Li:

During an inspection of your firm located in Huaian, China on March 30 through April 2, 2009, an investigator from the United States Food and Drug Administration (FDA) determined that your firm manufactures surgical devices. 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 (CFR), Part 820. We received a response via facsimile from the firm's US Agent Luis Arguello on August 26, 2009. Mr. Arguello forwarded Mr. Li Datong, General Manager's response dated August 25, 2009, concerning our investigator's observations noted on the Form FDA 483, Inspectional Observations that was issued to you. 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 result of a process cannot be fully verified by subsequent inspection and test that the processes 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,

(a) Your firm was unable to provide records to show qualification of the heat sealing processes for its intended use. The firm uses heat sealing machines for packaging individual product units, product cartons and shipping containers/boxes before sterilization.

(b) The inspection found that your firm does not have validation data for all (b)(4) sterilizers. The validation data that you provided did not identify the (b)(4) sterilizers on which the validation was performed and there was no data for the remaining two sterilizers.

Your firms's response dated August 26, 2009, to the observation is not adequate. In reference to the qualification of the heat sealing equipment, the firm plans to reassess and complete their validation during the first quarter. However, no documentation was provided to support this statement. In reference to the (b)(4) sterilizer validation, you stated that your firm now has validation documentation for all sterilizers; however, no documentation was provided to support this statement.

2. Failure to establish and maintain adequate procedures for identifying valid statistical techniques required to establish, control, and verify the acceptability of process capability and product characteristics in production and process control systems, as required by 21 CFR 820.250.

For example, for inspecting absorbable suture material per (b)(4) the firm uses (b)(4) criteria for sampling that is not in accordance with GB-2828-1-2003/ISO 2859-1 1999. This Reference for Sampling by Attributes states that if the acceptance number is above the acceptance level, then reject the sampled lot without retesting. The firm's procedure allows for retesting if the initial sampling test fails.

Your firm's response, dated August 26, 2009, is not adequate because your response did not respond to this observation.

3. Failure to establish and maintain an adequate complaint handling system in which complaints are evaluated to determine whether the complaint represents an event which is required to be reported to FDA under part 803, Medical Device Reporting, as required by 21 CFR 820.198(a)(3).

For example, your firm does not have a procedure to evaluate complaints to determine whether, the complaint represents an event that is required to be reported to FDA. Your complaint form fails to have a section in the form to document your firm's decision to report or not to report an event as an MDR. The agreement/contract between the US firm DemeTECH and your firm does not include procedures or references for reporting events to the FDA under 21 CFR 803. As a US agent for Huaiyin, the firm DemeTECH is responsible for reporting any reportable events to FDA.

Your firm's response dated August 26, 2009, is not adequate. In your firm's written response, Mr. Li states that the firm revised their complaint procedure. However a revised procedure was not included in the response to support this statement.

You should take prompt action to correct the violations addressed in this letter. Failure to promptly correct these violations 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 per 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. Please provide a translation of documentation not in English to facilitate our review.

Your response should be sent to: Thomas C. Knott, Chief, General Surgery Devices Branch, Office of Compliance, Center for Devices and Radiological Health, 10903 New Hampshire Avenue, W066-3520, Silver Spring, MD 20993-0002. If you have any questions about the content of this letter please contact: Thomas C. Knott at (301) 796-5770 or by FAX at (301) 847-8137.

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 a determine the causes of the violation(s), and take prompt actions to correct the violation(s) to bring your products into compliance.



Timothy A. Ulatowski
Office of Compliance
Center for Devices and
Radiological Health