In this warning letter breakdown, we are going to examine how you can avoid purchasing control citations and how to ensure there is not a breakdown in QMS when dealing with third party manufacturers.
Reference From Actual Warning Letter
“2. Failure to establish and maintain procedures to ensure that all purchased or otherwise received products and services conform to specified requirements, as required by 21 CFR 820.50. For example:
a. Your firm’s quality audit procedure requires an audit for critical suppliers be conducted at least once every three years. However, your firm’s critical suppliers of raw materials and services have not been audited in more than three years.
b. Your firm’s written contract with its sub-assembly contract manufacturer does not require the contract manufacturer to notify your firm of any changes in the products or services which may affect the quality of a finished device.
We reviewed your firm’s response and conclude that it is not adequate. Your firm did not review its current supplier qualification records to evaluate whether any existing or potential deficiencies may have resulted in nonconforming products. Also, your firm did not demonstrate that supplier audits have been completed. Additionally, your firm did not review supplier agreements to collect information on changes made without a notification, and evaluate how those changes could have impacted product quality.”
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