The FDA cited Osteotech over inadequate sanitation and product deviation investigations.
The FDA issued a Form 483 to the firm following a July/August inspection of its Eatontown, New Jersey facility, where investigators found the facility’s environmental controls did not ensure aseptic processing. As a result, gram-positive bacillus was identified in several product samples.
The agency also found that the material used to stopper bottles under vacuum and for lyophilization of soft tissue was not tested for microorganisms. In addition, the employee responsible for loading the product was not monitored for microorganisms.