1Data integrity
Audit trail review procedures for production software are general and do not contain instructions soecific to the different softwares to ensure a thorough review ofraw data.
Inspection Record
Biocon Biologics Limited — FDA 483 Findings
View the regulator's official source The source document is always the basis for judgement.
Findings
2Stability and storage
There have been no procedures established to identify and investigate out oftrend (001) or unexpected results dw-ing stability testing.
3Deviation, CAPA, and investigation
There are multiple deviations (>10) regarding exceeding hold times in drug product manufacturing.
4Equipment and facility
Production supervisors are given access to delete results in the [ <6TT-4jntegrity testing equipment.
5Aseptic processing and sterility assurance
The environmental monitoring trending program forL :poes not include evaluation ofroute of ingress into the aseptic areas grades A and B for recovered fungi/mold an gram-negative organisms.
6Computer system validation
The electronic data for thg(lon-viable patticleF2-APC-05 showed results that failed to meet acceptance criteria,, which had not been reporte in the paper records.
7Deviation, CAPA, and investigation
Deviations 177060, 129067, and 131819 are related to drug product spilling into the fill line through an air vent filter.
8Aseptic processing and sterility assurance
During review of equipment, there were at least 40 work orders opened for aseptic area equipment repairs
About this record
Extracted automatically from the document US FDA published on 2024-09-06. The source is available at the link above.
This is a record of that moment. Inspection findings are usually followed by the company's response and corrective action, but this page does not know how that turned out. Do not read it as the current state; check the regulator's official announcements for the latest status.
Translation and classification are automated and may differ in nuance from the source.
