Wednesday, September 27, 2017

Warning Letter of the Week: honest QA manager editions

A love note from the Center for Drug Evaluation and Research to the general manager of Shandong Vianor Biotech Co., Ltd:
2.    Your firm failed to establish an adequate quality control unit with the responsibility and authority to approve or reject all components, drug product containers, closures, in-process materials, packaging materials, labeling, and drug products (21 CFR 211.22(a)). 
Your laboratory analysis revealed that [redacted] lot [redacted] was subpotent. However, the certificate of analysis (CoA) provided showed that it was within specification. When questioned about why the CoA reported passing results even though the batch actually failed, your quality unit manager stated, “I made a mistake.”

3.    Your firm failed to clean, maintain, and, as appropriate for the nature of the drug, sanitize and/or sterilize equipment and utensils at appropriate intervals to prevent malfunctions or contamination that would alter the safety, identity, strength, quality, or purity of the drug product beyond the official or other established requirements (21 CFR 211.67(a)).

Our investigator observed what appeared to be rusted and corroded screws, [redacted] fluid and debris, and metallic mesh material on the product contact surfaces of [redacted] located in your facility.

Access to information during inspection
During the inspection, you initially barred our investigator from accessing a room identified as a laboratory. You eventually allowed the investigator to inspect the laboratory, but he found that it contained no equipment. You then stated that the laboratory was offsite at a [redacted] residence and that you could not give our investigator access as it was not a convenient time.
I think "I made a mistake" was a new one for a warning letter.  


  1. It's only a mistake if you get caught.

  2. Laboratory offsite at a residence... i.e. somebody's kitchen.


looks like Blogger doesn't work with anonymous comments from Chrome browsers at the moment - works in Microsoft Edge, or from Chrome with a Blogger account - sorry! CJ 3/21/20