Biocon Biologics Limited – FDA 483, Jun 3, 2017

The FDA Form 483 inspection revealed numerous deficiencies at the facility, impacting sterile drug product manufacturing and quality control.

**Facility and Operations:** The facility manufactures sterile injectable drug products, including "Injection, mg/ml," which has observed visible particulates since August 2015 and is still sold in Uruguay, Russia, and the Dominican Republic.

**Violations and Observations:**

* **Investigations:** Inadequate investigations into unexplained discrepancies and visible particulates, failing to extend to other batches or products. * **Risk Assessments:** No risk assessments performed after critical SOP updates (Microbiological Monitoring, Aseptic Process Simulation, Data Handling Systems Management) to assess impact on marketed products. * **Sterilization & Aseptic Processing:** * Inadequate validation of sterilization processes. * Lack of tracking for aseptic personnel and qualification requirements during media fills. * Media fill activities and filling times are not tracked comprehensively. * Sterile glove test not validated. * HVAC validation and requalification procedures do not account for microbial levels. * Deficient environmental monitoring systems and unspecified monitoring locations. * Aseptic operators held to Grade B qualifications despite working in Grade A areas. * Personnel monitoring held to Grade B specifications, except for Grade A glove testing. * Procedures to prevent microbiological contamination are not established, written, or followed.