WARNING LETTER

Creation Technologies LP MARCS-CMS 608364 — June 05, 2020

Delivery Method:: VIA UNITED PARCEL SERVICE
Product:: Medical Devices

Recipient:: Recipient Name

Michael A. Meyer; Recipient Title

Operations Leader; Creation Technologies LP; 8999 Fraserton Court
Burnaby BC V5J 5H8
Canada

Issuing Office:: Center for Devices and Radiological Health; United States

WARNING LETTER

June 5, 2020

Dear Michael A. Meyer,

During an inspection of your firm located in Burnaby, Canada on March 2, 2020 through March 5, 2020, an investigator from the United States Food and Drug Administration (FDA) determined that your firm manufactures the neoBLUE neonatal phototherapy unit. 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 Michael A. Meyer, Operations Leader dated March 27, 2020 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 establish and maintain procedures for corrective and preventive action, as required by 21 CFR 820.100(a). For example:

a. Quality data is not analyzed to identify existing and potential causes of nonconforming product, or other quality problems

i. A review of nonconforming data revealed there are (b)(4) nonconformances in a status of “Active – Waiting for Disposition Completion,” and (b)(4) in a status of “Active – Disposition Completed/Waiting for Approval.” These nonconformances are within a date range of January 2019 through June 2019. Your CAPA system does not have any records to demonstrate that a CAPA was opened to determine root cause, and the appropriate corrective and preventive actions to address the failure identified in the nonconformance.

ii. Multiple records for complaints and internal issues in 2018, 2019, and 2020 contain blank fields for the root cause; this has not been analyzed by you to determine if corrective action is necessary.

b. CAPA records lack objective evidence of all corrective actions or of effectiveness checks being completed. For example:

i. CAR 183A-0078 was open for nonconforming printed circuit board (PCB) (with an open NCR 173N-1045) was distributed to the customer. The CAPA record indicates that it was closed January 02, 2019 however, the record is incomplete in that the fields to identify the implemented corrective and preventive actions are blank. The report indicates that these activities should have been documented by June 14, 2019. As of the date of this inspection, you did not have an updated document to demonstrate that the corrective and preventive actions for this CAR Report were actually implemented.

ii. CAR 193A-005 was open for 4 NCRs raised due to a total of (b)(4). The CAPA was closed on October 3, 2019, however you were not able to provide objective evidence to support verification of effectiveness for board placement on conveyor during the next build as described in Section 4, Action 3, Item 2.

iii. CAR# 173A-0071 was open to address both FDA 483 observations from the 2017 inspection. However, for 2017 FDA-483 observation related to inadequate procedures for acceptance of incoming product, you did not perform any corrective or preventive actions to address problem. For the observation related to inadequate process validation procedures, the related CAPA was closed on May 27, 2019, without documenting any actual corrective action. You subsequently performed a corrective action to revalidate fixture #3992 on June 28, 2017, but the CAPA was not appropriately updated to demonstrate that you addressed the root cause of problem.

We reviewed your firm’s response and conclude that it is not adequate for the following reasons:

Your response stated a root cause analysis determined that quality data is not being analyzed for relevant fields and defect category trending because a focus was placed on addressing the issues described in the actual NCRs. You also stated that quality data trending did not take place across multiple Customer Focused Teams, as each customer has different requirements. For example, material cosmetic, workmanship standards and product mechanical requirements varies per customer. A previously used Creation NCR/CAPA system allowed for blank fields in the template (b)(4). Examples of observed incomplete CAPA records were entered in the old system. Since June 2019, a new tool named (b)(4) was adopted. This tool does not allow the root cause field to be left blank. You implemented a staff retraining on March 25, 2020 and committed to performing an Overall Quality Data Trending to identify and analyze NCR’s on a quarterly basis. However, you did not retrospectively assess the open CAPAs to determine the appropriate root cause and identify the appropriate corrective/preventive action.

Your response stated that some of your Quality Engineers had a lack of awareness and training in managing issues resulting in CAPAs which did not have a documented verification of effectiveness. As a result of this issue, you updated the CAPA SOP (Document C-0001298, 3-25-2020, Revision G), to identify the requirement to specifically verify effectiveness of the CAPA, and to provide objective evidence that the CAPA was successfully completed. However, the training provided was only conducted with your Quality Engineering Staff, and it is unclear whether the rest of the organization (i.e. Your Quality SOP defines the following roles: (b)(4) is aware of their roles to ensure that this procedure is effectively implemented. Additionally, you have not retrospectively assessed open CAPA investigations.

Your response stated that you will continue to leverage problem-solving methods such as (b)(4) etc., to identify the true root cause and continue to measure the effectiveness of the Corrective Actions. To prevent this from occurring in the future, you have added an escalation process whereby CAPA investigations open for more than (b)(4). This response is inadequate because your approach does not provide a plan to retrospectively assess open CAPA investigations.

2. Failure to establish and maintain procedures that define the responsibility for review and the authority for the disposition of nonconforming product, as required by 21 CFR 820.90(b). For example:

Process for disposition of nonconforming product does not prevent unacceptable units from being distributed without documented justification for use.

a. NCR ID 173N-1045 was opened for the (b)(4). Your NCR captures that product that was shipped to the customer was identified as defective and requested to be returned to Creation Technologies to be scrapped.

b. NCR 193C-0313 was opened on April 23, 2019 for a complaint from Intuitive Surgical that (b)(4) used in the customer’s surgical system were misprogrammed and returned. However, the NCR references CAR 193A-0025 , dated March 18, 2019, which demonstrates that (b)(4) from (b)(4) were reported to have previously had the same errors described in NCR 193C-0313. As a corrective action to CAR 193A-0025, the subject (b)(4) were reprogrammed as part of the rework. You could not provide evidence to identify the disposition of the boards reworked as part of CAR 193A-0025 and could not explain the disposition of the remaining (b)(4) boards, as you could not trace the serial numbers of the nonconforming product because those were not identified in the record. You did not reach out to (b)(4) about discrepancy.

We reviewed your firm’s response and conclude that it is not adequate for the following reasons:

Your response states the previous CAPA SOP did not have complete details of what is required for containment actions. This resulted in CAPA administrators, Quality Engineers, having inconsistencies in completing containment actions. Furthermore, the initial information that was entered in the customer NCR was not consistently validated for accuracy when the customer NCR was escalated to CAPA. You have updated the CAPA SOP by adding a statement for containment action to be (b)(4). The new CAPA SOP also identifies all of the parties responsible for completing the CAPA action. This response is inadequate because it does not identify whether existing records were evaluated to determine if there are other instances where nonconforming product was distributed and determined if action was necessary to mitigate the associated risks.

Your response stated that when an NCR was initiated, relevant information including the chronology of activities performed to address the issue, was not captured properly. You updated the SOP (b)(4) to state that, (b)(4) The SOP further elaborates that the documentation will be similarly attached when an NCR is escalated to a CAPA. Although you have performed employee training, the response did not address a plan for assessing records for other discrepancies where defective components that were reworked in a CAR, and distributed, were subsequently returned by the customer for the same failure affecting the device as part of the original CAR.

3. 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:

a. A supplier that failed to meet the requirements in the procedure did not have their status changed per the procedure.

b. The requirements that must be met by suppliers categorized as “Distributor – Strategic” on the Approved Supplier List was not listed in the procedure.

We reviewed your firm’s response and conclude that it is not adequate for the following reasons:

Your response stated supplier status changes and Supplier monitoring referred to in your SOP (b)(4) was not followed due to a lack of awareness by the responsible parties. (See Section 4.0 of the SOP for a list of the company functions who are responsible for adhering to this SOP). You updated the procedure and committed to performing training on the SOP in April 2020. As of the date of this review, the Agency does not have any indication from you that the training was conducted. Also, you did not evaluate the existing suppliers list to determine if there are other suppliers who have not been monitored per Section 7.7 of your SOP. For suppliers who might be determined to ‘not meeting’ supplier monitoring requirements, or being labeled as ‘restricted,’ your SOP does not require an evaluation of the product that the supplier provides, to assess the potential impact to the safety and effectiveness of Creation Technologies’ finished medical devices.

You stated the (b)(4) did not include the definition of (b)(4), as this was a typo in the document and the corrective action was to update the procedure. You did not plan to evaluate the approved supplier list and existing supplier control data to determine if there are other suppliers that are not being handled properly.

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 by 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: Establishment Support, Regulatory Inspections and Audits Team, White Oak Building 66, 10903 New Hampshire Ave., Silver Spring, MD 20993. Refer to CMS case # 608364 when replying. If you have any questions about the contents of this letter, please contact: CDR Nikhil Thakur at 301-796-5536 or Nikhil.Thakur@fda.hhs.gov.

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.

Sincerely yours,
/S/

Benjamin R. Fisher, PhD
Director
OHT 3: Office of Reproductive, Gastro‐Renal,
Urological, General Hospital Device & Human Factors
Office of Product Evaluation and Quality
Center for Devices and Radiological Health

CC: Timothy S. Holzschuh
US AGENT
500 Corporate Circle Golden, CO 80401