BD Gets Form 483 Over Calibration, GDP Issues

Becton Dickinson Caribe received an FDA Form 483 for inadequate calibration certificates for its product-counting scales. According to the FDA inspector, the San Lorenzo, Puerto Rico, facility failed to state the range of use on certificates dated Feb. 8, 2012, and Jan. 18 of this year. Additional flaws related to the certificates were redacted from the May 9 Form 483. The company does not always follow its good documentation practices procedure, the form states.
The GMP Letter