Warning Letter: CAPA Procedures Not Established

WARNING LETTER

Techlem Medical Corporation was issued a warning letter from the FDA. Excerpts from a warning letter of interest to software professionals:

CMS# 671395

Techlem Medical Corporation

Mississauga ON

December 26, 2023

Inspection Dates: June 19, 2023, through June 22, 2023

Inspection Issue(s):

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.

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. 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.

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.

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.

For more information, see the link below:

Techlem Medical Corporation – 671395 – 12/26/2023 | FDA

 

About the author

Allison joined SoftwareCPR in 2022, bringing along over ten years of passion for building teamwork and growth in organizations. This is established in part by the greatest University the South has to offer- Mississippi State.

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