FDA 483 - Bausch & Lomb Incorporated - February 25, 2016

This FDA Form 483 document details observations from an inspection, indicating significant deficiencies in the facility's quality control and manufacturing processes.

**Key Violations and Observations:**

* **Inadequate Investigations:** Written records of investigations into unexplained discrepancies lack conclusions and follow-up. Investigations are incomplete, and potential root causes are not consistently identified. Specifically, there was no scientific justification for root causes assigned to action level excursion investigations for non-viable particle testing on aseptic filling lines. An investigation report submitted was incomplete, failing to identify the root cause or propose effective corrective actions. No investigation was conducted into a particle count test failure for a post-simulated use test for a submission stability batch. Nonconformance Investigation Report (NCR) #540800, concerning leaking HEPA filters found in October 2015, was deemed inadequate. * **Environmental Monitoring Deficiencies:** Environmental sampling is not conducted under dynamic conditions, contrary to SOP 72-001, section 6.5.2. The written environmental sampling program is inadequate due to a lack of scientific justification for sampling locations. * **Airflow and Particulate Control Issues:** Smoke studies are insufficient to demonstrate unidirectional airflow and sweeping action over and away from critical processing areas under dynamic conditions in the ophthalmic filling area's classified areas. There is no assurance that the firm's current method for monitoring non-viable particulates during aseptic processing is reliable. *