Wednesday, January 25, 2017

Warning Letter of the Week: copy-and-paste edition

A dispatch from the Center for Drug Evaluation and Research to the Sales Manager of Suzhou Pharmaceutical Technology Co., Ltd in Suzhou, China: 
1.    Failure to transfer all quality or regulatory information received from the API manufacturer to your customers.
You omitted the name and address of the original API manufacturer on the certificates of analysis (CoA) you issued to your customers, and did not include copies of the original batch certificate.

For multiple API, you generated CoA by copying and pasting analytical results from the original API manufacturer, replacing the manufacturer’s information with your letterhead, then issuing these CoA to your customers. You omitted critical information including the original manufacturers’ names and addresses and the names, addresses, and telephone numbers of laboratories that performed the testing.

Customers and regulators rely on CoA for information about the quality and sourcing of drugs and their components. Omitting information from CoA compromises supply-chain accountability and traceability, and may put consumers at risk.
2.    Failure to have a quality unit responsible for reviewing and approving all appropriate quality-related documents, including Certificates of Analysis.
Your firm has no Quality Unit. During the inspection, you provided no written documents describing the roles and responsibilities of a Quality Unit. You had no written procedures for quality activities.

Your salespeople signed your CoA under the title "QC Director." Without performing tests, your salespeople also signed under "Tested By." Your response states your salespeople will no longer sign under these headings on CoA. Your response is inadequate because you did not provide sufficient detail of your corrective actions, nor address the validity of CoA issued previously. 
Well, it's a small company, people wear a lot of hats, you know...

2 comments:

  1. Hey Mike,

    Don't sweat it! That warning letter means nothing. They're just FDA bureaucrats trying to justify their existence and enormous paychecks by enforcing job-killing regulations, 75% of which are unnecessary. If they weren't there, they'd be "working" for the EPA.

    Don't let those killjoys dampen your entrepreneurial spirit. Keep using technology. They wouldn't have put cut-and-paste in the software if they didn't want you to use it.

    ReplyDelete
  2. Feel sorry for whoever is getting those drugs!!

    ReplyDelete