DMC Medical Technology & Manufacturing Co., Ltd. 9/12/12
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Department of Health and Human Services
|Public Health Service|
Food and Drug Administration
10903 New Hampshire Avenue
Silver Spring, MD 20993
September 12, 2012
VIA UNITED PARCEL SERVICE
Mr. Brian Wixted
DMC Medical Technology & Manufacturing Co., Ltd.
AI, 2nd Building, 6th Technology Road
High Technology Industrial Zone
Heyuan City, Guangdong Province, 5I7000 China
Dear Mr. Wixted:
During an inspection of your firm located in Heyuan City, Guangdong Province 5I700, China, on April 23 through April 25, 2012, an investigator from the United States Food and Drug Administration (FDA) determined that your firm manufactures polycarbonate syringes, polycarbonate connectors, and vein irrigation cannula. 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 16, 2012, concerning our investigator’s observations noted on the Form FDA 483 (FDA 483), List of Inspectional Observations, that 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 verify or validate corrective and preventive action to ensure that such action is effective and does not adversely affect the device, as required by 21 CFR 820.100(a)(4). For example, Preventive and Corrective Action Report (PCAR) 11092601 and PCAR 11100401 do not include verification that the corrective actions were effective and do not adversely affect the finished device.
2. Failure to document all required activities under 21 CFR 820.100, as required by 21 CFR 820.100(b). For example, PCARs 11090701, 11092601, and 11100401 do not include documentation of all of the actions taken to correct or prevent the recurrence of the quality problem.
We reviewed your firm’s response and conclude that it is not adequate. While your firm promised to inspect the production records for both the 10 ml and 20 ml syringes and review and evaluate all changes to specifications and processes and deviations, your firm has provided no evidence of this review and evaluation.
3. Failure to review and evaluate processes and perform revalidation where appropriate when changes or process deviations occur, as required by 21 CFR 820.75(c). For example, your firm was operating outside the validated parameters for (b)(4). (b)(4). There was no documented review or evaluation of the deviations.
We reviewed your firm’s response and conclude that it is not adequate. While your firm has promised to review and approve all process deviations, and document the deviation and reason for acceptance by June 15, 2012, your firm has provided no evidence of this having been completed.
4. 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, all of the critical defects identified by your firm during the in-process quality control were accepted as is. There is no documented justification for use of these nonconforming products. There is no documentation of the need for the determination for an investigation related to the identified critical defects.
The adequacy of your firm’s response cannot be determined at this time. While your firm has stated that (b)(4) had been implemented, there is currently no way of verifying the information, since the records submitted are not in English.
5. Failure to establish and maintain acceptance procedures, where appropriate, to ensure that specified requirements for in-process product are met, as required by 21 CFR 820.80(c). For example, your firm’s Standard Inspection Process states that (b)(4) is to follow (b)(4), your firm’s Standard Sampling Plan. Additionally, it states that critical defects are to be (b)(4) (i.e., (b)(4)). None of the samples in which critical defects were found were rejected. All of the syringes found with critical defects were reworked and released for distribution by the firm.
The adequacy of your firm’s response cannot be determined at this time. There is currently no way of verifying the information, since the records submitted are not in English.
6. Failure to establish and maintain procedures to adequately control environmental conditions where environmental conditions could reasonably be expected to have an adverse effect on product quality, as required by 21 CFR 820.70(c). For example:
a) Your firm’s Workshop Environmental Control Procedure requires microbiological monitoring of the hand and working table to be conducted (b)(4). However, there is (b)(4) documentation of microbiological monitoring in April 2011.
b) The Workshop Environment Control Procedure also states that, if there is an “out of control” result, a CAPA should be initiated to conduct an investigation. However, particle counts were documented on November 6, 2011, above the specification of (b)(4). No CAPA was initiated to address these “out‑of‑control” results.
c) The specification range for temperature in the clean room is (b)(4) ºC, as stated on the Workshop Environment Monitoring Report. However, (b)(4) examples from November 2011 through April 2012 were observed outside of this specified range. No CAPA was initiated to address these “out-of-control” results.
The adequacy of your firm’s response cannot be determined. Your firm states that the out-of-specification findings identified on November 6, 2011, were not documented as CAPAs, because (b)(4), causing the particle count to exceed specification. In addition, your firm states that (b)(4) had been used, but not documented. Your firm further states that the reason the temperature was documented out of range for periods between November 2011 and April 2012, was because, after checking the specification (b)(4), the temperature range in place at that time was (b)(4). Your firm also determined that outside parameter readings should be documented and evaluated through a CAPA, in accordance with the Environmental Control Procedure. Additionally, your firm has opened CAPA 016 to address the environmental control issues for this observation. While your firm has identified failure to comply with the Environmental Control Procedure as the reason for the lack of documentation of microbiological monitoring, your firm has not provided evidence of retraining of employees on the procedure.
7. Failure to establish and maintain device master records (DMR), as required by 21 CFR 820.181. For example:
a) Your firm’s DMR does not contain or refer to the (b)(4) for each of the (b)(4) colors for the (b)(4) syringe; only (b)(4) of the (b)(4) were included or referenced by the DMR.
b) The product specification is supposed to cover all syringe sizes and colors. However, there is no product specification specific to the (b)(4) syringe included or referenced by the DMR.
c) There was no (b)(4) for the (b)(4) syringe in the location referenced by the DMR.
d) The (b)(4) for the (b)(4) manufactured by your firm for the (b)(4) syringe were not included or referenced by the DMR.
We reviewed your firm’s response and conclude that it is not adequate. While your firm has stated that (b)(4) was added to the DMR for all syringe colors, a (b)(4) specification was added to the DMR, a (b)(4) report was added to the DMR, and that your firm would file the (b)(4), your firm has not provided evidence of having implemented or retrained your firm’s employees on the changes to, and maintenance of, the DMR.
8. Failure to establish and maintain procedures for identifying training needs and ensure that all personnel are trained to adequately perform their assigned responsibilities, as required by 21 CFR 820.25(b). For example, (b)(4) of the employees identified as being responsible for (b)(4) have received training related to the GMP requirements pertaining to their particular job function, including how the job relates to the (b)(4).
We reviewed your response and conclude that it is not adequate. While your firm stated that all personnel would be retrained by May 8, 2012, it has provided no evidence of the training having taken place.
9. Failure to establish and maintain procedures for quality audits and conduct such audits to assure that the quality system is in compliance with the established quality system requirements and to determine the effectiveness of the quality system, as required by 21 CFR 820.22. For example, your firm’s procedure for internal quality audits calls for an audit plan to be prepared in (b)(4) for the (b)(4); however, there was no Internal Audit Plan for (b)(4).
We reviewed your firm’s response and conclude that it is not adequate. Your firm has promised to revise and improve the internal audit system and review and evaluate all changes to specifications and processes and deviations. However, your firm has have provided no evidence of the revision or the review and evaluation.
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 action (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 #327539 when replying. If you have any questions about the contents of this letter, please contact: Carl Fischer, Branch Chief, General Hospital Devices Branch at 1-301-796-5771 (phone) or 1-301-847-8137 (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
Cc: Mr. Andy Song General Manager/Owner
DMC Medical Technology & Manufacturing Co., Ltd.
AI, 2nd Building, 6th Technology Road
High Technology Industrial Zone
Heyuan City, Guangdong Province, 5I700 China