Techlem Medical Corporation - 671395 - 12/26/2023 (2024)

WARNING LETTER

December 26, 2023

Dear Dr. Sinha,

During an inspection of your firm located in Mississauga, Canada on June 19, 2023, through June 22, 2023, an investigator from the United States Food and Drug Administration (FDA) determined that your firm manufactures wheeled stretchers. 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 your firm dated July 17, 2023, 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 adequately establish procedures for implementing corrective and preventive action, as required by 21 CFR 820.100(a). For example:

a. On June 19, 2023, your President confirmed CAPA procedures have not been established.

b. As a result of your firm’s February 2023 audit, an observation was found that the welding equipment used in the manufacture of the devices needed to be fixed since it was “not penetrating”. The affected parts were replaced as identified on the firm’s Annual Audit Finding document. However, the following could not be provided:

• Investigation into how long the welding equipment was not performing adequately,
• Testing and the effectiveness of the corrections made to the welding equipment, and
• Ensuring the adequacy of the three-month cleaning schedule.

Your response dated July 17, 2023, is not adequate. Your firm developed and submitted a CAPA procedure, CA-003 – Corrective and Preventive Action; however, it is deficient in several ways. The following are some, but not all areas of your CAPA procedure that are deficient:

• Under Procedure, External Complaints, it states “When an external non-conformance occurs, and when applicable, Techlem Medical Corporation responds in a manner best suited to the customer’s needs.” This statement is ineffective as it gives no specific direction. The procedure should identify the action(s) needed to correct and prevent recurrence of nonconforming product and other quality problems. There is no mention in the CAPA procedure of verifying or validating the corrective and preventive action to ensure that the action is effective and does not adversely affect the finished device.
• There is no mention in the CAPA procedure of ensuring that information related to quality problems or nonconforming product is disseminated to those directly responsible for assuring the quality of such product or the prevention of such problems.
• There is no mention in the CAPA procedure of submitting relevant information on identified quality problems, as well as corrective and preventive actions, for management review.

2. Failure to adequately establish procedures for quality audits, as required by 21 CFR 820.22. For example: You stated that you perform internal quality system audits annually; however, you lacked procedures for the internal quality audits. Your response dated July 17, 2023, is not adequate. Your firm developed and submitted your Internal Audit procedure, IA-007; however, you did not provide evidence of implementation of the newly developed procedure.

3. Failure to establish and maintain a design history file for each type of device, as required by 21 CFR 820.30(j). For example: Your design control procedure as identified in the Quality Manual section Research and Development does not include a requirement to establish and maintain a design history file. You did not establish a design history file and you lacked the requirement to establish and maintain one.

Your response dated July 17, 2023, is not adequate. You submitted your Quality Manual, which under the Research and Development section, on page 10, requires that a design history file be established and maintained by Quality Assurance. However, you did not provide evidence of implementation of this requirement. You also submitted your Design Control Procedure, DC-004; however, the procedure does not address the requirement to establish a design history file.

4. Failure to adequately document acceptance activities to include the signature of the individual conducting the acceptance activities, as required by 21 CFR 820.80(e). For example: On page 23 of your Quality Manual it states, “At conclusion of final inspection, the OC Inspector will sign off on the Inspection Report.” However, 16 final inspection sheets reviewed during the inspection did not have a sign off signature or release date. The adequacy of your response dated July 17, 2023, cannot be determined at this time. You submitted a blank Techlem Medical – Final QC Inspection Sheet, which contains a space for the signature and release date; however, you did not provide evidence of implementation of this revised form.

5. Failure to adequately establish and maintain procedures to ensure that device history records for each batch, lot, or unit are maintained to demonstrate that the device is manufactured in accordance with the device master record and the requirements of 21 CFR 820, as required by 21 CFR 820.184. For example: The Quality Manual procedure does not define where labeling for the finished devices will be maintained.

The adequacy of your response dated July 17, 2023, cannot be determined at this time. The Quality Manual does not address labeling, but your firm has since developed DHR-016, Device History Record, that addresses where labeling for the finished devices will be maintained. However, you did not provide evidence of implementation of DHR-016, Device History Record.

6. Failure to adequately establish and maintain the requirements, including quality requirements, that must be met by suppliers, contractors and consultants, as required by 21 CFR 820.50(a). For example: A Vendor Approval Form is used to gather information about a potential supplier. This form requires three references to confirm the status of the potential supplier. The procedure, Purchasing-Vendor Approval section of the Quality Manual does not include this requirement of three references. Thus, the procedure does not adequately establish and maintain the requirements used to evaluate and select potential suppliers. For example, by stating how many good references are needed for approval of the supplier.

Your response dated July 17, 2023, is not adequate. You submitted your revised Quality Manual and a new purchasing SOP, POR-011 – Supplier Approval. In addition, you submitted a Supplier Approval Checklist.. Your purchasing SOP, POR-011 – Supplier Approval, appears to contain all the information stipulated under 21 CFR 820.50, Purchasing Controls. However, the requirements used to evaluate and select potential suppliers are still unclear. Neither the revised Quality Manual, the new Supplier Approval SOP, nor the Supplier Approval Checklist contain a requirement of three references to qualify a supplier and it is unknown whether the Approved/Preferred Vendor Application Form containing the three-reference requirement is still being used or if it was superseded by one of the new documents submitted. Additionally, you did not submit evidence of implementation and you did not indicate whether you will conduct a retrospective review of your existing suppliers to determine if the suppliers have met the defined requirements.

7. Failure to adequately establish procedures to control document changes, as required by 21 CFR 820.40(b). For example: Several of your revised documents lack a revision number, a release signature of the approving individual(s), and a date of approval.

Your response dated July 17, 2023, is not adequate. Your firm lacked document control procedures and therefore, developed and submitted COR-002 – Control of Records. A portion of the purpose statement of this document is as follows: “To ensure the documents are Reviewed, Approved, Updated, and distributed and stored in a controlled manner.” However, the document does not address document approval, nor does it address document changes.

Our inspection also revealed that your firm’s wheeled stretchers are misbranded within the meaning of section 502(t)(2) [21 U.S.C. § 352(t)(2)], in that there was a failure or refusal to furnish any material or information required by or under section 519 of the Act, 21 U.S.C. § 360i, respecting these devices. In particular, 21 CFR 801.20(a) requires, with exceptions not relevant here, that the label and device package of every medical device bear a unique device identifier (UDI) that meets the requirements of 21 CFR Part 801, subpart B, and 21 CFR Part 830. And 21 CFR 830.300(a) and 830.320(b) – both of which were promulgated under section 519 of the Act, among other provisions – require that the labeler of a device submit electronically to FDA’s Global Unique Device Identification Database (GUDID) the information required by 21 CFR Part 830, subpart E, for each version or model required to bear a UDI. FDA has determined that your firm causes a label to be applied to a device with the intent that the device will be commercially distributed without any subsequent replacement or modification of the label. Techlem Medical Corporation is therefore a “labeler” within the meaning of 21 CFR 830.3, and has not submitted to GUDID any information required by 21 CFR Part 830, subpart E, respecting these devices.

The failure or refusal to furnish any notification or other material or information required by or under section 519 of the Act, 21. U.S.C. § 360i, also constitutes a prohibited act under section 301(q)(1)(B) of the Act, 21 U.S. C. § 331(q)(1)(B).

Your response dated July 17, 2023, is not adequate. Your firm submitted evidence that you have obtained UDIs; however, a search of the GUDID database on October 17, 2023, did not reveal any entries.

Other federal agencies may take your compliance with the FD&C Act and its implementation 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.

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 address 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. 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 email to CDRHWarningLetterResponses@fda.hhs.gov or by mail to Food and Drug Administration, Center for Devices and Radiological Health, Office of Regulatory Programs, Division of Regulatory Programs 2, FDA Regulatory Inspections and Audits Team, White Oak Building 66, 10903 New Hampshire Ave., Silver Spring, MD 20993.Refer to CMS case #671395 when replying. If you have any questions about the contents of this letter, please contact: David Wolloscheck at 301-796-1480.

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.

Sincerely yours,
/S/
Courtney H. Lias, Ph.D.
Office Director
OHT 3: Office of GastroRenal, ObGyn,
General Hospital and Urology Devices
Office of Product Evaluation and Quality
Center for Devices and Radiological Health