- HanChuan FuMo Plastics 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|
Silvet· Spring, MD 20993
MAY 13, 2015
VIA UNITED PARCEL SERVICE
HanChuan FuMo Plastics Co., Ltd.
56 Zhengjie Rd., Chenghuang
431600 Hanchuan, Hubei
During an inspection of your firm located in 56 Zhengjie Rd., Chenghuang, Hanchuan, Hubei, China, on January 12, 2015, through January 14, 2015, an investigator from the United States Food and Drug Administration (FDA) determined that your firm manufactures non-surgical isolation gowns. 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 February 2, 2015, concerning our investigator’s observations noted on the Form FDA 483 (FDA 483), List of Inspectional 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 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, your firm contracts out the manufacturing of the isolation gowns. However, your firm did not evaluate suppliers of isolation gowns on the basis of their ability to meet your firm’s specifications.
We reviewed your firm’s response and conclude that it is not adequate.
Your firm revised the purchasing control procedure to include quality control requirements. However, your firm did not indicate that it would re-audit its suppliers to ensure that the suppliers meet the quality control requirements. Also, your firm did not provide personnel training records on the revised purchasing control procedure.
2. Failure to establish and maintain procedures for acceptance of incoming product, as required by 21 CFR 820.80(b). For example, your firm does not follow its established sampling plan for the incoming product inspection for isolation gowns.
Your firm’s response did not address this observation.
3. Failure to establish and maintain procedures for implementing corrective and preventive action, as required by 21 CFR 820.100. For example, your firm 's corrective and preventive action (CAPA) procedure does not include the requirements for:
a. Analyzing the sources of quality data to identify the existing and potential causes of nonconforming product, or other quality problems, and using appropriate statistical methodology to detect recurring quality problems;
b. Verifying or validating the corrective and preventive action to ensure that such action is effective and does not adversely affect the finished device; and
c. Disseminating information related to quality problems or nonconforming product to those directly responsible for assuring the quality of product or the prevention of problems.
We reviewed your firm’s response and conclude that it is not adequate. Your firm revised its CAPA procedure to include the above requirements. However, your firm did not conduct a retrospective review quality data sources to ensure that they were adequately evaluated to identify quality problems. Your firm also did not conduct a retrospective review of its CAPAs to ensure that the CAPA activities were adequately conducted. In addition, your firm did not provide personnel training records on the revised CAPA procedure.
4. Failure to establish and maintain procedures for receiving, reviewing, and evaluating complaints by a formally designated unit, as required by 21 CFR 820.198(a). For example, your firm’s customer complaint handling procedure does not require that:
a. The complaints are evaluated to determine whether the complaint represents an event which is required to be reported to FA under 21 CFR 803, Medical Device Reporting (MDR);
b. The complaints are evaluated to determine if an investigation is necessary; and
c. The complaints are processed in a uniform and timely manner.
We reviewed your firm’s response and conclude that it is not adequate. Your firm revised the customer complaint handling procedure and “Regulations on after sales-service procedure.” However, your firm’s revised procedures do not describe how complaints are evaluated for MDR reportability, nor has your firm conducted a retrospective review of complaints to determine if they are reportable to the FDA. In addition, your firm did not provide personnel training records on the revised procedures.
5. Failure to establish procedures for quality audits, as required by 21 CFR 820.22. For example, your firm’s internal audit procedure does not specify:
a. What elements of the quality system will be audited;
b. When a re-audit of deficient matters will be conducted; and
c. That the quality audits need to be conducted by individuals who do not have direct responsibility for the matters being audited.
We reviewed your firm’s response and conclude that it is not adequate. Your firm revised its internal audit procedure to include the above requirements. However, your firm did not provide personnel training records on the revised procedure. In addition, your firm did not conduct a retrospective review of past audits to ensure compliance with 21 CFR 820.22.
Our inspection also revealed that your firm’s devices are misbranded under 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 (MDR). Significant violations include, but are not limited to, the following:
6. Failure to adequately develop, maintain and implement written MDR procedures, as required by 21 CFR 803.17(a)(1). For example, your firm does not have written MDR procedures.
We reviewed your firm’s response and conclude that it is not adequate. Your firm provided an MDR procedure. However, this procedure does not:
a. Establish internal systems that provide for timely and effective identification, communication, and evaluation of events that may be subject to MDR requirements. For example, the procedure does not include definitions for the terms “become aware” and “caused or contributed”, found in 21 CFR 803.3 and the definition for the term “reasonably suggests,” found in 803.20(c)(1). The exclusion of the definitions for these terms from the procedure may lead your firm to make an incorrect reportability decision when evaluating a complaint that may meet the criteria for reporting under 21 CFR 803.50(a).
b. Establish internal systems that provide for timely transmission of complete medical device reports. Specifically, the following are not addressed:
i. The procedure does not contain or refer to instructions for how to obtain and complete the FDA 3500A form;
ii. The circumstances under which the firm must submit supplemental or follow-up reports, as required by 21 CFR 803.56; and
iii. How your firm will submit all information reasonably known to it for each event.
In addition, your firm’s MDR procedure included references to baseline reports. Baseline reports are no longer required and we recommend that all references to a Baseline Report be removed from your firm’s MDR procedure (see: 73 Federal Register Notice 53686, dated September 17, 2008).
The eMDR Final Rule requiring manufacturers and importers to submit electronic Medical Device Reports (eMDRs) to FDA was published on February 13, 2014. The requirements of this final rule will take effect on August 14, 2015. If your firm is not currently submitting reports electronically, we encourage you to visit the following web link for additional information about the electronic reporting requirements:
If your firm wishes to discuss MDR reportability criteria or to schedule further communications, it may contact the Reportability Review Team by email at ReportabilityReviewTeam@fda.hhs.gov
Given the serious nature of the violations of the Act, the devices manufactured by your firm, including the non-surgical isolation gowns, 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 is taking steps to refuse entry of these devices into the United States, 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 regarding the adequacy of your firm’s response and the 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.
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 (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 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 Inspections Support Branch, White Oak Building 66, Rm 2622, 10903 New Hampshire Ave., Silver Spring, MD 20993.Refer to CMS case # 453627 when replying. If you have any questions about the contents of this letter, please contact: Daniel Walter, Chief, Foreign Enforcement Branch, at +1 (301) 796-5587, or fax +1 (301) 847-8139.
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.
Jan B. Welch, MHS, MT (ASCP) SBB
Office of Compliance
Center for Devices and
77 West St., Apt. 1
Malden, MA 02148