- Handsome Industrial (H.K.) 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|
Silver Spring, MD 20993
AUG 4, 2014
VIA UNITED PARCEL SERVICE
Hong Bo Chen
Director and Owner
Handsome Industrial (H. K.) Co., Ltd (HIC)
No 155 Xinhua Rd.
Guongzhou, Guangdong 510470
Dear Ms. Chen:
During an inspection of your firm located in Guongzhou, Guangdong, China,on March 24, 2014, through March 27, 2014, an investigator from the United States Food and Drug Administration (FDA) determined that your firm manufactures electrical heating pads, also known as Heating Blanket Slimming Body Care Device, Slimming Body Suit, Slimming Suit, and Far-infrared Slimming Suit. 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 April 17, 2014, 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 for receiving, reviewing, and evaluating complaints by a formally designated unit, as required by 21 CFR 820.198(a).
For example, your firm does not have a written procedure for complaint handling, nor has it designated a formal unit to review complaints.
We reviewed your firm’s response and conclude that it is not adequate. The response stated that your firm is developing an SOP for complaint handling, to be completed by May 31, 2014. However, no procedure was provided, nor did your firm discuss whether it will conduct a retrospective review of complaints (such as the complaint that initiated a re-design of the Slimming Suit controller) to ensure compliance with 21 CFR Part 820.198.
2. 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 does not have a procedure for the control of nonconforming product.
We reviewed your firm’s response and conclude that it is not adequate. The response states that a nonconforming product procedure is being written, to be completed by “June 31st, 2014 (sic).” However, no procedure or draft procedure was provided for review, and no evidence was provided in the response to indicate that your firm has considered the potential negative effects (risk analysis) to safety and effectiveness of the electrical heating pad devices due to the lack of a nonconforming product procedure.
3. Failure to establish and maintain procedures for identifying product during all stages of receipt, production, distribution, and installation, as required by 21 CFR 820.60.
For example, a variety of unidentified incoming material, in-process product, and finished products in various locations of the receiving area, sewing workshop, electrical workshop, and final testing/packaging room were observed by the investigator during the inspection.
We reviewed your firm’s response and conclude that it is not adequate. Your firm states that it has reviewed all inventory and labeled each batch accordingly. However, no evidence was provided in the response that materials and products are appropriately segregated, or controlled, by procedure and personnel training.
4. 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:
a. Your firm’s “Design Control Standard Operating Procedure,” dated 2010.05.01, does not identify and describe interfaces with different groups or activities that provide or result in input to the design and development process, or designate the individuals responsible for review and approval of the design input, design review, design verification, and design validation.
b. Your firm does not have an established design change procedure. When the Slimming Suit (heating pad) device controller was updated to a new design as a result of a customer complaint, these changes were not made in accordance with design controls in that they were not documented, validated or verified, reviewed, and approved prior to implementation.
c. Your firm did not establish a design history file (DHF) for the Heating Blanket Slimming Body Care Device.
d. Your firm did not have a design transfer procedure to ensure that the device design is correctly translated into production specifications.
Your firm’s response to part (a) appears to be adequate. The response provided an updated segment of the design control procedure that identifies responsible parties for design control processes and responsibilities for the design input process.
We reviewed your firm’s response for parts (b)-(d) and conclude that it is not adequate. Your firm is creating a design change procedure to be completed by April 10, 2014. However, no procedure or draft procedure was provided for review, nor did your firm indicate if it would conduct a retrospective review of previous design changes for similar deficiencies.
Your firm’s response states that the design history file will be complete by “June 31st, 2014 (sic).” However, it is not clear if all required design activities that produce records needed in the DHF have been completed.
Your firm’s response states that a design transfer SOP is being written, to be completed by July 31, 2014. However, no evidence was provided in the response to demonstrate that your firm has examined the potential negative effects (risk analysis) on safety and effectiveness of the Slimming Suit due to the lack of a design transfer procedure.
5. Failure to document corrective and preventive action activities, as required by 21 CFR 820.100(b).
For example, your firm failed to document its root cause analysis, investigation activities, and corrective action verification for Report Number (b)(4), involving the Heating Blanket Slimming Body Care Device. Additionally, Report Numbers (b)(4) and (b)(4) lack the closing approval signature and date. According to your firm’s Director, both cases are considered closed.
We reviewed your firm’s response and conclude that it is not adequate. Your firm states that the CAPA records are being revised to ensure documentation of signatures and root cause analysis. Additionally, your firm is reviewing the investigations, with a completion date estimated to be May 31, 2014. However, without the completed root cause information, it is not clear if your firm has considered whether its corrective actions for Report Number (b)(4) will need to be modified.
Given the serious nature of the violations of the Act, electrical heating pad devicesmanufactured 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 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 #432723 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.
Steven D. Silverman
Office of Compliance
Center for Devices and