The Symptoms Make the Diagnosis Inevitable

US-FDA just hammered Greco Gas, Inc.  The Warning Letter told Greco they must (among many other requirements) provide:

“A description of how you will test each component lot for conformity with all appropriate specifications for identity, strength, quality, and purity.”

FDA also found that Greco failed to calibrate numerous pieces of equipment.  “For example, your pressure and vacuum gauges had not been calibrated since November 2020, despite subsequent continued manufacturing of medical gases using this equipment.”

It’s not that Greco employees were not aware of the problems.  FDA reports that:

• “Filling operators stated that they document assay testing results for Oxygen, USP despite another individual conducting the testing.
• Filling operators stated that they duplicate the results from oxygen analyzer calibrations between production records without performing the testing.
• Testing results for Nitrogen, NF were reported on production records without the equipment necessary to perform the testing.”

The company’s violations extend much deeper than the tip of the iceberg that FDA shouts into the Warning Letter.  Greco’s problems emanate from the core of their corporate culture.  They will not be fixed by rewriting procedures and retraining the workers.  FDA knows that.  That’s why the WL tells them:

“Based upon the nature of the violations we identified at your firm, you should engage a consultant qualified as set forth in 21 CFR 211.34 to evaluate your operations and to assist your firm in meeting CGMP requirements.”

FDA also strongly recommends that Greco hire a data integrity consultant because “Your quality system does not adequately ensure the accuracy and integrity of data to support the safety, effectiveness, and quality of the drugs you manufacture.”

Imagine what this company would be doing if FDA were not holding them accountable.  The ironic thing is that in their rush to skimp on quality and send more profits to their owners, they are probably doing neither.  Greco’s absurdly poor Quality culture is driven by incompetent management.  That bad management can only bungle financial decisions as well.

How do I know that?  VCI has been inside a lot of companies.  The symptoms make the diagnosis inevitable.

How about you?  Do you know someone who depends on a medical gas?  Comment below.