FDA 483 - Wockhardt, Ltd. - December 15, 2015

The FDA inspection of a pharmaceutical manufacturing facility revealed multiple quality system and manufacturing deficiencies.

**Quality Unit Oversight and Documentation:** * Lack of Quality Unit oversight/approvals for document destruction, with shredded raw material labels, maintenance work orders, and hot work permits found awaiting incineration. * An uncontrolled personal diary containing experimental protocol and laboratory data, including calculations and molecular weights, was found in the Process Development Laboratory, which handles quality failure investigations and process testing. * Record entries were not always made contemporaneously or permanently, and corrections did not always preserve the original entry.

**Laboratory Control Issues:** * Aseptic media fill sterility testing for the Aseptic processing area used finished sterile API containers, but remaining containers were sampled but not tested for sterility, only retained for failure investigation. * Worst-case locations for microbial environmental swabs and contact plates in the sterile production area were not identified. * Three out of ten sterile gowns had unraveled stitching threads (1-3 cm) and one had shredded boot strap ties (>10 cm) in the sterile manufacturing block. * Lack of traceability for environmental isolates recovered from the production area, and microbial cultures were stored together in the same bag. * Operator interventions, including hand movements, interfered with unidirectional airflow during aseptic connections in a Laminar Air Flow unit, as observed in a smoke study simulation report.

**Computerized System Deficiencies:** * Prior to July