The FDA issued a warning letter to India’s Mahendra Chemicals after finding a data and document disaster at its API plant in Ahmedabad. Now the agency has taken the step of banning all of the company’s products produced at the facility.
Often the FDA puts companies on its import alert list before it even issues a warning letter. But this time around, the agency waited two years to take the action. The FDA added the plant to its most recent import alert list updated Aug. 25, banning all human and animal drugs produced at the facility.
In the warning letter issued in July 2015, the agency scolded the drugmaker after inspectors found that some records were had forged signatures of directors who were not in the plant when they were supposedly signed and some signatures that were backdated to indicate they approved drugs before they were shipped, when in fact they hadn’t.
The FDA gave the facility a five-point directive, ordering it to investigate the “inaccuracies” and report back about how extensive the data inaccuracies were. It wanted to know what impact they had on the products the company had shipped to the U.S. and to report on how it intended to solve the problems.
The problems were discovered during an inspection in May 2014 of the company’s plant in Gujarat. Inspectors found that operators often logged batch records on “rough notes” that were later destroyed after being “transcribed” by someone else, leaving open the question of what the original data was and if it was altered in the final form.
Aug 30, 2017