Phrase: "Puerto Rico"
Puerto Rico was the site of FDA inspections last year. And several big pharma companies got warning letters regarding manufacturing practices there. As mentioned previously, during a March inspection of Bristol-Myers Squibb's Manati, Puerto Rico plant, investigators determined the company "has not established or followed appropriate written procedures designed to prevent microbiological contamination of drug products purporting to be sterile."
In addition, the regulator says the company hasn't provided assurance that your clean room gown supplier has implemented appropriate actions to prevent a reoccurrence of defective gowns being used in your clean rooms. "It is your responsibility to ensure that your clean room gown supplier has adequate inspection procedures to remove damaged gowns. There is no mention in your investigation of a decision to shorten the life span of [garments] to prevent the excessive wear found during your investigation."
But BMS wasn't the only one that ran afoul of the FDA. The agency issued a warning letter to Eli Lilly about its API production facility in Puerto Rico, stating that the company failed to adequately investigate problems with manufacturing ingredients used to make its diabetes treatment Humalog.
Johnson & Johnson's McNeil Healthcare unit has had a rough year. In January, the company received a warning after an inspection of its pharmaceutical manufacturing facility at Las Piedras, Puerto Rico. The inspection identified significant violations of cGMP.
And it is in this letter that we read about the complaints of a mildew-like odor related to several OTC drug products due to 2,4,6 Tribromoanisole (TBA) contamination. TBP is a pesticide and flame retardant used to treat wooden pallets. The contamination was first noted in 2008 and occurred again in 2009.