BMS Puerto Rico Plant Warned for Repeat GMP Issues

The FDA has warned Bristol-Myers Squibb’s (BMS) Manati, Puerto Rico, facility for repeat GMP deviations and recommended the company hire a third-party consultant to assess its procedures.

A March 17 to 31 inspection found operators repeatedly failed to comply with the company’s aseptic operations procedures, according to the letter.

Repeat citations from prior inspections indicate the quality control unit is either not appropriately exercising its responsibilities or does not have the authority to carry them out, the letter says.
Drug GMP Report