German regulators have pulled the manufacturing certificate from a Dr. Reddy’s formulation plant located in Bachupally, India, following an inspection earlier this month that uncovered deficiencies in record-keeping for quality control and sanitation systems at the facility.
The Government of Upper Bavaria - Central Authority for Supervision of Medicinal Products in Bavaria announced the action on the EudraGMDP website.
The latest inspection of the plant, conducted Aug. 1, found critical deficiencies in essential elements of the Pharmaceutical Quality System at the facility that were rooted in “staff-errors.” It said that out-of-spec results were systematically invalidated in hundreds of cases without traceable and scientifically based root cause analysis.
The agency said “protocol, review and reporting systems are designed and executed in a way to systematically not document and report ‘discrepancies, non-conformances, incidents and unusual events.”
Cleaning of rooms and direct-product-contact equipment was not verifiable or not successfully performed but was documented as having been done in batch manufacturing/packaging records.
The facility cited by the German regulators is not the same plant cited in a Form 483 by the FDA in May. In that inspection, a plant in Bachupally received a Form 483 with 11 observations.