The FDA cited drug manufacturer Aurobindo Pharma for inadequate computer access controls and written procedures.
Following a December inspection of Aurobindo’s Hyderabad, India, facility, the agency issued a Form 483 noting the facility lacked appropriate controls for computer systems to ensure only authorized employees had access to master production and control records.
The facility also lacked written procedures to avoid contamination of sterile drug products. The quality control microbiology laboratory lacked documentation for spiked endotoxin vials used during one 2016 qualification cycle. Unexplained anomalies or failures in batches or their specifications were not thoroughly reviewed, according to FDA.
Inspectors found the facility’s quality control unit did not approve and review changes to written procedures, including four action items completed in late 2016 that were not documented. The facility also failed to include validation batches in its process validation reports.