cGMPs / Over-the-Counter

FDA Warns Closed OTC Plant Not to Reopen Without Serious Improvements


Nov 05, 2015

The FDA has posted a warning letter this week sent to Indianapolis-based aspirin and acetaminophen maker American Family Pharmacy in July.

The warning outlines serveral serious violations of good manufacturing practices observed during a June 22–July 8, 2014 inspection.

According to the letter, American Family Pharmacy informed the FDA investigator that the plant ceased all operations May 2014, but intends to resume operations once more funds are available. Because the FDA feels AFP's response letter lacks sufficient corrective actions, the agency wants to be informed if production is resumed.

The letter cited GMP violations including: lots of 81 mg aspirin tablets, produced over five months, were all given a single lot number; the company distributed multiple lots of 81 mg aspirin tablets without finished product testing; batches of aspirin and acetaminophen tablets were not evaluated for stability and thus their expiration dates are not based on any supportive stability studies; and aspirin tablet containers were missing warning labels.

Read the FDA Warning Letter