Inspections, Compliance, Enforcement, and Criminal Investigations
Ningbo Huahui Medical Instruments Co., LTD 7/16/12
Department of Health and Human Services
|Public Health Service|
Food and Drug Administration
|9200 Corporate Boulevard|
Rockville MD 20850
July 16, 2012
VIA UNITED PARCEL SERVICE
Mr. Byron Pan
Ningbo Huahui Medical Instruments Company Limited
Ningbo, P.R. China 315191
Dear Mr. Pan:
During an inspection of your firm located in Ningbo, P.R. China, on April 16, 2012, through April 18, 2012, an investigator from the United States Food and Drug Administration (FDA) determined that your firm manufactures thermometers and blood pressure monitors. 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. Your firm’s response, dated May 9, 2012, to the Form FDA 483 (FDA 483), was not reviewed because it was not received within fifteen business days of issuance of the FDA 483. The response may be evaluated along with any other written material provided in response to the violations cited in this Warning Letter. These violations include, but are not limited to, the following:
1. Failure to establish and maintain procedures to control the design of the device in order to ensure that specified design requirements are met, as required by 21 CFR 820.30(a).
For example, when requested by the investigator, your firm could not provide any documented evidence to verify that the following design control requirements were completed for the Digital Thermometer Model MT-518: 1) design input, 2) design output, 3) design verification, 4) design validation, and 5) design review. Your firm stated that it lost the design documents last year.
2. Failure to establish and maintain adequate procedures for receiving, reviewing, and evaluating complaints by a formally designated unit, as required by 21 CFR 820.198(a). For example:
A. Your firm’s Adverse Event Control Procedure, QP NBHH18.104.22.168-2010, dated 2010-10-8, does not contain a requirement that a complaint be evaluated to determine whether the complaint represents an event that is required to be reported to FDA under 21 CFR 803, Medical Device Reporting. For example, complaints dated 2009-11-09, 2010-02-03, and 2010-04-07 were not evaluated for potential medical device reporting.
B. Regarding complaints dated 2009-11-09, 2010-02-03, and 2010-04-07, your firm stated that it contacted the customers to discuss the complaints. However, your firm stated that it did not document the conversations with the customers. Section 7.2.3 of your firm’s Quality Manual, NBHH-ZS-2010, dated 09-08-2010, requires that records be kept when your firm communicates with customers.
3. Failure to adequately verify or validate the corrective and preventive action to ensure that this action is effective and does not adversely affect the finished device, as required by 21 CFR 820.100(a)(4).
For example, the reports for CAPA 2012-2-14 and CAPA 2012-1-05 do not contain evidence to indicate that the corrective actions taken were verified or validated as effective and did not adversely affect the finished device.
4. Failure to establish and maintain adequate procedures to control product that does not conform to specified requirements. The evaluation of nonconformance shall include a determination of the need for an investigation and notification of the persons or organizations responsible for the nonconformance. The evaluation and any investigation shall be documented, as required by 21 CFR 820.90(a).
For example, nonconforming product reports for PCB Board MT519 and PCB Board MT811 dated 2011-04-28 and 2011-06-23, respectively, do not include any justification to explain why no nonconformance investigation was conducted. Also, neither report contains evidence to verify that the person or organization responsible for the nonconformance were notified.
5. Failure to establish and maintain adequate procedures to control environmental conditions that could reasonably be expected to have an adverse effect on product quality, as required by 21 CFR 820.70(c).
For example, your firm’s Environmental Control Procedure, QZ/NHH01-2007, dated 2007-01-08, requires that personnel working (b)(4).
6. Failure to adequately document the equipment identification, calibration dates, the individual performing each calibration, and the next calibration date. These records shall be displayed on or near each piece of equipment or shall be readily available to the personnel using such equipment and to the individuals responsible for calibrating the equipment, as required by 21 CFR 820.72(b)(2).
For example, section 7.6.1.d of your firm’s Quality Manual, NBHH-ZS-2010, dated 09-08-2010, requires that testing equipment and measuring equipment in any service place shall have a clear status mark. However, (b)(4). did not have a calibration sticker or a calibration record on or near the equipment or readily available to personnel using the equipment and individuals responsible for calibrating the equipment.
7. Failure to establish and maintain procedures to control labeling activities, as required by 21 CFR 820.120.
For example, your firm stated that it has no procedures to control labeling activities.
8. Failure to include, or refer to the location, of the primary identification label and labeling for each production unit in the Device History Record (DHR), as required by 21 CFR 820.184(e).
For example, your firm stated that it does not put label information in the DHR for any of its medical products, such as the primary identification label and labeling in the DHR for Lot 110205.
Given the serious nature of the violations of the Act, thermometers and blood pressure monitors manufactured by your firm are subject to refusal of admission under section 801(a) of the Act, 21 U.S.C. § 381(a), in that they appear to be adulterated. As a result, FDA may take steps to refuse these products, known as "detention without physical examination," until these violations are corrected. In order to remove the devices from detention, your firm should provide a written response to this Warning Letter as described below and correct the violations described in this letter. We will notify you if your firm’s response appears to be adequate. We may need to re-inspect your firm’s facility to verify that the appropriate corrections and/or corrective actions have been made.
Also, 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 #314879 when replying. If you have any questions about the contents of this letter, please contact: Carl Fischer, Ph.D., at (301) 796-5770.
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