Dr. Reddy’s Facility Hit With Eight-Observation Form 483
A slew of observations related to control records, data integrity and manufacturing at Dr. Reddy’s Andhra Pradesh, India, facility resulted in a Form 483.
During a Nov. 17 to 21, 2014, inspection, FDA investigators found that the plant’s laboratory control records don’t include complete data from all tests done to ensure products meet specifications, including examinations and assays. Additionally, Dr. Reddy’s computerized systems don’t have proper controls in place to prevent unauthorized access or changes to data. Batch production and control records aren’t prepared directly after each batch of product is processed, the form says.
The facility also lacks a document control system to ensure that all documents are properly issued, revised and withdrawn. The firm also fails to justify or follow-up on investigations into batch failures, the investigator says. Dr. Reddy’s failed to adequately validate its API manufacturing process or doesn’t have scientifically sound sampling plans for validating APIs, according to the form.
Finally, the water the facility uses to make APIs hasn’t been proven suitable for its intended use. Incubated plates prepared just before the inspection were contaminated with bacteria and mold, the Form 483 says. The company’s microbiological testing methods haven’t been verified or validated to demonstrate that impurities in water can be recovered and identified during sample handling, preparation and incubation.
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