- New May King Plastic 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|
Silver Spring. MD 20993
APR 13, 2015
VIA UNITED PARCEL SERVICE
Mr. Shek King Li
President and Owner
New King May King Plastic, Ltd.
No. 26 Kung Lok Industrial Estate, Bao’an District
518100 Shenzhen, Guangdong
Dear Mr. Li,
During an inspection of your firm located in Shenzhen, Guangdong, China,on November 3, 2014, through November 6, 2014, an investigator from the United States Food and Drug Administration (FDA) determined that your firm manufactures Class I and Class II massagers. 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 your response, dated November 7, 2014, concerning our investigator’s observations noted on the Form FDA 483 (FDA 483), List of Inspectional Observations, which was issued to your firm. Your response was not evaluated because an English translation was not provided for review.
Violations include, but are not limited to, the following:
1. Failure to establish and maintain procedures for implementing corrective and preventive action, as required by 21 CFR 820.100(a). For example, corrective and preventive action procedure (b)(4) does not include requirements for:
a. Analyzing quality data to identify existing and potential causes of nonconforming product or other quality problems, using appropriate statistical methodology;
b. Verifying and validating corrective and preventive actions; and
c. Implementing and recording changes necessary to correct and prevent identified quality problems.
2. Failure to maintain complaint files, and 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 “Complaint Handling Procedure (b)(4),” does not require that complaints are processed in a uniform and timely manner, and does not ensure that complaints are evaluated to determine whether they are to be reported to FDA according to 21 CFR 803.
- Review of Corrective and Preventive Actions, dated 2009.7.3 and 2009.6.10, found your firm failed to document complaints upon receipt.
3. Failure to establish and maintain procedures to ensure that the device design is correctly translated into production specifications, as required by 21 CFR 820.30(h). For example, your firm does not have a design transfer procedure.
4. Failure to ensure that when the results of a process cannot be fully verified by subsequent inspection and test, the process 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, your firm failed to validate the (b)(4) process used in production of the plastic parts utilized in manufacturing the Verseo Wrap-A- Leg Air Massager (Verseo Air Pressure Massager). Additionally, your firm could not provide the installation qualification (IQ), operational qualification (OQ), or performance qualification (PQ) documentation for (b)(4), that are used to manufacture plastic parts for the Verseo Wrap-A-Leg Air Massager.
5. Failure to establish and maintain procedures to control product that does not conform to specified requirements, as required by 21 CFR 820.90(a). For example:
- Your firm’s nonconforming product procedure, "Failed Quality Control Procedure (b)(4),” does not adequately define disposition of nonconforming product. Specifically:
i. (b)(4) does not require the disposition of “obsolete” product to be documented.
ii. (b)(4) does not require the documentation of the justification for use of nonconforming product, or “use as is,” and the signature of the individuals authorizing the use.
- Nonconforming products found during manufacturing that can be repaired are documented on a daily repair sheet without further evaluation and analysis.
6. Failure to establish and maintain procedures for changes to a specification, method, process, or, as required by 21 CFR 820.70(b). For example, your firm's "Process Change Control Procedure (b)(4)” does not ensure changes are verified and where appropriate validated, or that changes to specifications, methods, processes, and procedures are documented and approved.
7. Failure to document all corrective and preventive action (CAPA) activities required under this section, and their results, as required by 21 CFR 820.100(b).
For example, your firm failed to adequately document CAPA activities for the following:
- (b)(4) does not adequately describe and document the details of the corrective and preventive actions taken or the date of CAPA closure.
- (b)(4) does not adequately describe the results of the investigation, the corrective action effectiveness activities, or the date of CAPA closure.
8. Failure to establish and maintain procedures to control all documents that are required by this part, as required by 21 CFR 820.40. For example, your firm’s Document Control Procedure (b)(4) establishes requirements for the review, approval and distribution of quality system procedures and records; as well as for document revision controls. However:
a. The (b)(4) procedure, (b)(4) Instructions, Customer Complaint report form, and the Instruction Manual for Verseo Wrap-A-Leg Air Massager were not controlled in that they lack a document number; document approval, including the date and signature of the approving individuals; and revision control.
b. An (b)(4), machine work instruction was revised by new instructional pictures superimposed and glued to the existing work instruction posted at (b)(4).
c. An uncontrolled copy of a sampling plan was observed under the glass top of the QC inspector's work table, and used in incoming material and product acceptance activities at the "IQC" station.
9. Failure to establish and maintain adequate procedures to ensure that equipment is routinely calibrated, inspected, checked, and maintained, and to include provisions for handling, preservation, and storage of equipment, so that its accuracy and fitness for use are maintained, as required by 21 CFR 820.72(a). For example, your firm could not provide the following:
- The 2012, 2013, and 2014 calibration records for (b)(4) used in incoming material acceptance inspection.
- The 2012, 2013, and 2014 calibration records for (b)(4) used for (b)(4) acceptance inspection.
- The 2012 and 2013 calibration records for (b)(4) device acceptance inspection Verseo Wrap-A-Leg Air Massage.
- The 2012 calibration records for (b)(4) acceptance inspection.
10. Failure to document acceptance activities required by this part, as required by 21 CFR 820.80(e). For example, your firm does not document the sample size used for, or results of, incoming material, in-process quality control functional testing, and finished device acceptance activities.
11. Failure to ensure that all equipment used in the manufacturing process meets specified requirements and is appropriately designed, constructed, placed, and installed to facilitate maintenance, adjustment, cleaning, and use, as required by 21 CFR 820.70(g). For example, your firm’s "Machine, Equipment Maintenance and Repair Procedure (b)(4)” requires that machinery and equipment must be inspected and maintained daily by the operator. However, the review of the 2013 and 2014 daily maintenance records for (b)(4) used in manufacturing the Verseo Wrap-A-Leg Air Massager revealed that your firm did not perform the daily maintenance activities for approximately 140 days in 2014, and approximately 215 days in 2013.
12. Failure to establish procedures for ensuring that all personnel are trained to adequately perform their assigned responsibilities and for identifying training needs were not established, maintained, and documented, as required by 21 CFR 820.25(b). For example:
a. Your training procedure, "Human Resources Management Control
Procedure (b)(4),” does not require that personnel must be made aware of device defects that may occur from improper performance of their specific jobs as part of their training.
b. Your firm does not have training records for the (b)(4) operation.
Given the serious nature of the violations of the Act, devices 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 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 violation(s) described in this letter. We will notify you regarding the adequacy of your firm’s response(s) 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 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 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. We will notify you regarding the adequacy of your firm’s response(s) 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 #448276 when replying. If you have any questions about the contents of this letter, please contact: Daniel Walter, Chief, Foreign Enforcement Branch, at 301-796-5587 (phone) or 301-847-8139 (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.
Jan B. Welch, MHS, MT (ASCP) SBB
Office of Compliance
Center for Devices and