- Delivery Method:
- VIA Electronic Mail
- Medical Devices
Recipient NameWenchao Ou
Recipient TitlePresident & CEO
- Forcemech International LLC
4111 Rice Drier Road, Ste. 1h
Pearland, TX 77581-2800
- Issuing Office:
- Office of Medical Device and Radiological Health Division 3
CMS # 634891
September 21, 2022
Dear Mr. Ou:
During an inspection of your firm located at 4111 Rice Drier Rd., Pearland, TX on March 28 through April 4, 2022, an investigator from the United States Food and Drug Administration (FDA) determined that your firm is a medical device manufacturer (i.e., repackager/relabeler) and initial distributor/importer of the Forcemech Navigator and Navigator XL Powered Wheelchair. 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 any function of the body.
Observations Pertaining to Quality System Regulation Provisions and Regulations
This inspection revealed that your 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. These violations include, but are not limited to, the following:
1. Failure to adequately maintain a device master record to include, or refer to the location of, the packaging and labeling specifications, including methods and processes used, as required by 21 CFR 820.181(d).
Specifically, your firm has not adequately established procedures to maintain your device master record (DMR), which shall include, or refer to the location of, information regarding your packaging and labeling specifications used to identify your powered wheelchair. For example, your firm’s devices are labeled with a 10-digit alphanumeric random serial number, and the coding system used to create that number has not been defined. Such random numbering is not compliant with the unique device identifier (UDI) regulation, 21 CFR Part 830 (as further noted below).
2. Failure to establish and maintain procedures to control labeling activities as required by 21 CFR 820.120.
Specifically, your firm has not developed procedures that define your packaging and primary identification label and labeling specifications/requirements for your new serial number tracking system. For example, your firm’s device user manuals and packaging are labeled with a 10-digit alphanumeric random serial number, and the coding system used to create that number has not been defined. Such random numbering is not compliant with the unique device identifier (UDI) regulation, 21 CFR Part 830 (as further noted below).
3. Failure to adequately establish procedures for acceptance activities, as required by 21 CFR 820.80(a).
Specifically, your firm’s Final Acceptance Inspection procedure (FM.SOP.12, Rev. 0, dated 7/15/2021) does not include all your product acceptance/release criteria listed in your Product Inspection Form (FM. Form.08) such as checking for sticker integrity, verifying the condition of all product accessories, verifying the manufacturer’s quality control records, and verifying the condition of the product manual and version. Your procedure fails to describe the process for assigning internal lot numbers for new products and the method used for tagging the lot to signify that the lot can be used for shipment. For example, the investigator observed during the inspection that you place a tag (internal ID label form) on the lots which passed final inspection for incoming finished products from your OEM supplier in (b)(4) and products that are returned by your customers. Your powered wheelchairs are inspected and documented on your product inspection form (Form 08) and quality control tag (Form 06). However, your Final Acceptance Inspection procedure does not cover the remaining inspection acceptance/release criteria for these elements and fails to define the requirements for assigning internal lot numbers for your finished devices.
4. Failure to adequately establish and maintain document control procedures, as required by 21 CFR 820.40.
Specifically, your firm has not maintained labeling changes to your User Instruction Manuals including your communications with the OEM supplier, description of the change, and signature approval and date. Review of your Document Control procedure (FM.SOP.11, Rev. 0, dated 6/5/2020) observed that you did not maintain adequate revision history of your user manual content changes or revision updates. For example, the investigator observed during the inspection that your Document Control procedure states that control of documents applies to all procedures. However, your firm’s device master record (DMR) did not include documents such as labeling artwork (logos) and product labeling. There is no label control procedure, and any document changes are directly sent to your OEM supplier for review and approval. Your Document Control procedure does not include detailed descriptions of the change(s) made to control documents, as well as the reason for the change.
5. Failure to adequately establish procedures for performing servicing activities and verifying that servicing meets specified requirements, as required by 21 CFR 820.200(a).
Specifically, your firm does not have procedures for servicing and inspection instructions for ensuring that your device will perform as intended after repair. There are no written procedures that define the requirements for distributing new replacement parts of your powered wheelchairs and supporting customers with installing such new replacement parts. For example, the investigator observed during the inspection that your Customer Service staff resolves technical issues and complaints by troubleshooting over the phone or it is resolved by shipping the customer a new replacement part or component. You firm has provided customers with special instruction (videos) on replacing/installing new parts/components. However, there is no assurance that the service is adequately performed in accordance with manufacturer’s instructions. Your quality system procedures fail to include the process for distributing/installing replacement parts, entering and tracking the information and results to completion, and analyzing the data, such that your firm could demonstrate proper installation of replacement parts.
You have not submitted a response to these observations. The violation cited in this Warning Letter is significant and your response will be evaluated along with any other written material provided in response to this Warning Letter.
Observations Pertaining to Other Regulations
In addition to being a manufacturer of the Class II Powered Wheelchair, your firm is a “labeler” of the device as defined in 21 CFR 801.3. The inspection revealed that your devices are misbranded within the meaning of section 502(c) of the Act, 21 U.S.C. §352(c), in that your firm failed to have on the label or labeling of the device information that is required by or under the authority of this Act. In addition, your devices are misbranded within the meaning of section 502(t)(2) of the Act, 21 U.S.C. §352(t)(2), in that there was a failure to furnish material or information required by or under section 519 of the Act, 21 U.S.C. §360i, respecting the device. Furthermore, it is a prohibited act under section 301(q)(1)(B) of the Act, 21 U.S.C. §331(q)(1)(B), to fail to furnish any notification or other material or information required by or under section 519 of the Act, 21 U.S.C. §360i.
These violations include, but are not limited to, the following:
6. Failure to ensure that the label of every medical device shall bear a unique device identifier (UDI) that meets the requirements of 21 CFR 801 Subpart B and 21 CFR Part 830, as required by 21 CFR 801.20(a).
Specifically, the label for the Navigator Series Wheelchairs repackaged and relabeled onsite for returned product does not include a UDI. Class II devices manufactured and labeled after September 24, 2016, must bear a UDI, unless an exception or alternative applies. No exception or alternative to the requirements of 21 CFR 801 Subpart B and 21 CFR Part 830 applies to the Navigator Series Wheelchairs manufactured and labeled after September 24, 2016. In addition, per 21 CFR 830.50(b), whenever you create a new device package, you must assign a new device identifier to the new device package; and per 21 CFR 830.60(a), if you relabel a device that is required to bear a UDI, you must assign a new device identifier to the device. Your firm performs onsite repackaging and relabeling operations for returned devices that pass final product inspection and are restocked for sale. These devices are repackaged in a new box and new serial number labels are printed and affixed to the box. However, these serial numbers are 10-digit alphanumeric randomly generated numbers not based on a defined coding system, and do not meet the UDI requirements.
7. Failure to provide required information to Global Unique Device Identification Database (GUDID) as required by 21 CFR 830.300(a).
Specifically, labelers of devices required to bear a UDI are required to submit specific data pertaining to these devices to FDA’s GUDID on or before September 24, 2016. Your firm has failed to submit the information required under 21 CFR Part 830 Subpart E for each version or model required to bear a UDI, as specified by 21 CFR 830.300(a).
Your firm should take prompt action to address any violations included in this letter. Failure to promptly address these violations may result in regulatory action being initiated by the FDA without further notice. These actions include, but are not limited to, seizure, injunction, and civil money penalties. Other federal agencies may take your compliance with the FD&C Act and its implementing regulations into account when considering the award of federal contracts. Additionally, should FDA determine that you have Quality System regulation violations that are reasonably related to premarket approval applications for Class III devices, such devices will not be approved until the violations have been addressed. Should FDA determine that your devices or facilities do not meet the requirements of the Act, requests for Certificates to Foreign Governments (CFG) may not be granted.
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 Quality Systems violations, as well as 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 completed1. Your firm’s response should be comprehensive and address all violations included in this Warning Letter. If you believe that your products are not in violation of the FD&C Act, include your reasoning and any supporting information for our consideration as part of your response.
Your firm's response should be sent via e-mail to: Jessica Mu, Director of Compliance Branch, U.S. Food and Drug Administration, Division 3, Office of Medical Device and Radiological Health Operations at firstname.lastname@example.org. Please identify your response with CMS case #634891 when replying. If you have questions regarding the content of this letter, please contact Compliance Officer, Charles J. Chacko at 214-253-4939, or via email at email@example.com.
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 any violations and take prompt actions to address any violations and bring the products into compliance.
Shari J. Shambaugh
Program Division Director
Office of Medical Device and Radiological Health
CAPT Nina Mezu-Nwaba, PharmD., MPH., MSc,
United States Public Health Service
OHT5: Office of Neurological and Physical Medicine Devices
Office of Product Evaluation and Quality
Center for Devices and Radiological Health
1 See the UDI Final Rule, 78 FR 58786, 58815-58816 (September 24, 2013). More information about compliance dates for UDI requirements can be found at FDA’s website (https://www.fda.gov/medical-devices/unique-device-identification-system-udisystem/udi-compliance-policies-and-udi-rule-compliance-dates#classII).