CRLs Should List the Third Party Manufacturer

It probably is good for the public interest, and frankly for the manufacturing ecosystem, for the FDA to be directed (and given the authority) to disclose the third party whose “facility-related deficiencies” identified during a Current Good Manufacturing Practices (cGMP) results in a CRL.

A little public shaming would probably help deal with widespread structural deficiencies amongst CDMOs.

Something certainly needs to happen, this is happening way to often.

Photo by Leah Newhouse on Pexels.com

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