Ongoing FDA Concerns with Procedure Compliance, Media Fill Practices and Environmental Excursions at BMS’ Manati, PR Plant Draw Warning Letter

Findings by FDA during a mid-March inspection at Bristol-Myers Squibb’s (BMS) injectable operations in Manati, Puerto Rico of problems with procedure and media fill compliance – previously noted in 2005 and 2009 inspections – contributed to a late-August warning letter to the firm.

FDA stressed in the warning letter that the repeat citations from prior inspections “indicate that your quality control unit is either not appropriately exercising its responsibilities or does not have the authority to carry out its responsibilities.”

Among the products manufactured at the Manati facility are Orencia, for rheumatoid arthritis, the anti-clotting drug Coumadin, and Abilify IM for treatment of schizophrenia.

In 2007, the company began construction of a $220 million expansion of the Manati plant, which included adding 100,000 square feet of new space and renovation of 30,000 square feet for filling and finishing of biological sterile products.  The construction was completed in 2009.

Topping the list of FDA’s concerns at the Manati facility was the “repeated” failure of operators to comply with the firms procedures for aseptic operations – for example, not following SOP requirements pertaining to interventions into the Class 100 (ISO 5) zone.

BMS stated in its response to the 483 that its SOPs are “inadequate and do not reflect actual practices,” and made a commitment to revise the procedures.  FDA responded in the letter that it expects BMS to “promptly correct all deficient procedures to ensure employees do not continue improper practices.”

[More on the dialogue between BMS and FDA on the agency’s inspection findings is provided for subscribers here.]