www.fdanews.com/articles/142544-sterility-483-warning-letter-show-failures-at-biolab
Sterility 483, Warning Letter Show Failures at Biolab
December 16, 2011
Knowledge of sterilization failures and failure to remedy them were among violations at Bayamon, Puerto Rico-based Biolab, an FDA Form 483 and subsequent warning letter state.
The GMP Letter
The GMP Letter