Safe, Pure, and Effective


In a recent USFDA warning letter an API manufacture was cited for failure to properly maintain buildings and equipment used in the manufacturing of APIs.  Additionally the company was cited for failure to complete data derived from testing and verification that released batches met specifications and standards.

In addition to the cGMP building, equipment, and laboratory data deficiencies two other concerning items were identified in the warning letter:

One item is the identification of a disparity in information provided during the inspection where the company identified one API that the facility imports and distributes to the US Market.  Thus during the inspection the FDA focused on this product.  However, USFDA reviewed import entries for this company and identified other APIs manufactured at this site and imported into the US both before and after the inspection.

The second item is that the company recognized that the facility and equipment did not meet cGMP requirements but continued to manufacture for the US market.  In the company’s response, they stated that they decided to divert the referred batches to the domestic (India) market.

For the first item, the company has been asked to provide an explanation as to the disparity between statements made during the inspection to USFDA and the resulting import records.  The second item poses an interesting legal and ethical question.  If the purpose of the cGMPs is to ensure safe, pure, and effective drugs for the consumer does it matter in which part of the world the consumer lives in (in this example the US or India)?  If the company recognizes their facility does not meet cGMP standards, should they continue to manufacture the product for non-US markets?  What is the corporate social responsibility for this company to insure their products are safe, pure, and effective?