Uh, oh: Here's an ominous line from the recently posted FDA warning letter to Perrigo, a Michigan manufacturer of non-prescription, store-branded drugs: "Be advised that FDA expects that your corporate management will undertake a comprehensive evaluation of manufacturing operations to ensure compliance with CGMP."
It sounds like the regulator may be finishing up its internal review of guidelines for selecting corporate executives to prosecute for consistently substandard manufacturing.
The warning letter follows the Perrigo response to the FDA following a mid-Nov 2009 through mid-Jan 2010 inspection. The drugmaker, according to the warning, failed to reject a lot of ibuprofen tablets that had been contaminated with metal shavings. The company segregated the contaminated lot portion, but then shipped a subportion. The entire lot was then recalled.
The company also came up short in its investigation into why a foreign tablet appeared in its filling equipment. A lot of brown, oval ibuprofen caplets contained a brown, round tablet. In addition Perrigo failed also to inspect a lot of orange, round ibuprofen tablets, which had been packaged between the oval and round brown pills. "There is no assurance that this lot was not also contaminated," according to the letter.
The regulator notes a trend: "FDA investigators documented your firm's failure to follow Standard Operating Procedures (SOPs) during the last three FDA inspections, as well as in other inspections since 1998."
Concerning the pill mixup, the letter states that Perrigo has had a program in place since 2005 to address the matter, but consumer complaints continue. "Please indicate how you intend to implement, support, and sustain a comprehensive quality system that is consistent with CGMP."
- here's Warning Letter 2010-DT-11