Warning Letter: C&M Oxyfill

Warning letter: C&M Oxyfill

On May 26, the US Food and Drug Administration’s New Orleans, Louisiana, district office sent a warning letter to C&M Oxyfill (Wiggins, MS) concerning violations of current good manufacturing practice (CGMP) regulations at the company’s compressed oxygen manufacturing facility.

The cited CGMP violations include:

  • failure to establish certain laboratory controls;

  • failure to routinely calibrate, inspect, or check automatic, mechanical, or electronic equipment;

  • failure to ensure that all production and control records were reviewed and approved by the quality control unit to determine compliance;

  • failure to establish adequate batch production and control records for each batch of drug product produced.

In addition, the letter warned that the compressed oxygen cylinders manufactured by C&M are misbranded because the product’s labels do not have the required statement “Rx Only” prominently placed so it would be likely to be read and understood by an ordinary individual under customary conditions of purchase and use.