- Shanghai Neo-Medical Import & Export 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
NOV 2, 2015
VIA UNITED PARCEL SERVICE
Shanghai Neo-Medical lmport & Export Co., Ltd.
Room 2004, B/D3
183 Huai Hai Xi Road
Dear Mr. Zhang:
During an inspection of your firm located in Shanghai, China, on July 20, 2015, through July 22, 2015, an investigator from the United States Food and Drug Administration (FDA) determined that your firm manufactures surgical masks. 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 Lu Ru, Export Manager, dated August 4, 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 establishand maintain procedures for implementing corrective and preventive action (CAPA), as required by 21 CFR 820.100(a). For example two procedures exist for the handling and processing of corrective and preventive actions. However, neither procedure requires:
a. Analysis of all quality data sources in order to identify existing and potential causes of nonconforming product or other quality problems.
b. Documentationof verification/validation for planned corrective and preventive action in order to ensure that the action does not adversely affect the finished device.
c. Submission of CAPAs for management review.
We reviewed your firm's response and conclude that it is not adequate. While you indicated that you will revise your procedure, the response did not state when the procedure will be revised. Your firm's response did not include a plan to ensure past CAPAs are adequately evaluated and maintained in accordance with accordance with the new procedure. In addition, the response did not include a plan to train personnel to execute the new procedure
2. Failure to establish and maintain procedures for maintaining complaint files, as required by 21 CFR 820.198(a). For example, "Customer Complaint and Feedback Control System," document NMITS201410, does not require:
a. Evaluation of each complaint within a specified time period in order to determine if is required to be reported to FDA as a Medical Device Report (MDR), under 21 CFR Part 803.
b. Maintenance of a record of investigation of required information, including: name of the device; name, address, and phone number of the complainant; dates and results of the complaint investigation; what corrective actions were taken in response to the complaint; and if any reply were made to the complainant.
We reviewed your firm's response and conclude that it is not adequate. While you indicated that you will revise your procedure, the response did not state when the procedure will be revised. Your firm's response did not include a plan to ensure past complaints are adequately evaluated and maintained in accordance with accordance with the new procedure. In addition, the response did not includea plan to train personnel to execute the new procedure
3. Failure to establish and maintain procedures to ensure that all purchased or otherwise received product and services conform to specified requirements, as required by 21 CFR 820.50. For example, "Purchasing Control Program," document TC-QP06, does not require:
a. Documentation of evaluations of potential suppliers, contractors, and consultants.
b. Description of the type and extent of control over the products, services, suppliers, contractors, and consultants.
c. Maintenance of records of acceptable suppliers, contractors, and consultants.
We reviewed your firm's response and conclude that it is not adequate. The response does not include a retrospective review to determine whether a review will be conducted of current agreements with suppliers in order to determine whether new agreements between suppliers/contractors and consultants will be necessary to comply with its revised procedure. Additionally, the response did not state when procedures will be revised and when personnel will be trained to execute the new procedure
4. Failure to establish and maintain device master records (DMRs), as required by 21 CFR 820.181. For example, your firm did not develop a device master record for surgical masks.
We reviewed your firm's response and conclude that it is not adequate. Your response stated a device master record will be created for the surgical mask; however, it is unclear if a review of documentation will be conducted for other applicable devices to determine whether a device history record is needed for such devices.
Our inspection also revealed that your firm's surgical masks devices are misbrandedunder section 502(t)(2) of the Act, 21 U.S.C. §352(t)(2), in that your firm failed or refused to furnish material or information respecting the device that is required by or under section 519 of the Act, 21 U.S.C. § 360i, and 21 CFR Part 803 - Medical Device Reporting. Significant violations include, but are not limited to, the following:
5. Failure to develop, maintain and implement written MDR procedures, as required by 21 CFR 803.17. For example, your firm does not have an MDR procedure for reporting adverse events to the US FDA.
We reviewed your firm's response and conclude that it is not adequate. Your firm did not provide an MDR procedure in its response.
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 Shanghai Neo-Medical lmport& Export Co. Ltd.
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 (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 implementationof 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. 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.
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 #47744 when replying. If you have any questions about the contents of this letter, please contact LT David Dar, Acting Chief, Foreign Enforcement Branch, at firstname.lastname@example.org
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.
CAPT Sean M. Boyd, MPH, USPHS
Office of Compliance
Center for Devices and Radiological Health
US Med-Pharm Supplies, Inc.
38129 Spring Canyon Drive
Murrieta, California 92563