USFDA483 to Aurobindo’s Eugia US Site Says No QC Unit

USFDA audit of Eugia US Manufacturing in New Jersey, US (FEI 3015534630) resulted in issuance of USFDA 483 with 10 observations. The inspection was performed from 11-22 December 2023 by investigators James R Birkenstamm, Daniel L Zheng, Ruben C Quintana, Yoriann M Cabrera Bartolomei. The USFDA 483 observations include

1. System for cleaning and disinfection of aseptic clean rooms are deficient, no validation documented; Also failure to assess safety and effectiveness of cleaning agents.
2. No QC Unit; Open CAPAs, Deviations, OOS Investigations beyond due date, Lack of control on third party vendors for pest control, management of software applications, HVAC qualifications, Do not have knowledge of  access control of software’s used.
3. Inadequate building control: Lapses in pressure cascading of aseptic clean rooms, monitoring, qualification. Damaged ceiling, HVAC mezzanine; Construction activities in operational areas.
4. Inadequate control on Computer systems and processes: Shared Empower software system and admin controls with another company, lack of user access controls on software applications, IT systems and personnel, contracts and agreements with service providers.
5. Computer records are not checked for accuracy, Controls on addition or deletion of data are unclear
6. Lapses in Equipment Qualification, Operational procedure for equipment
7. Systems for monitoring environmental conditions in aseptic area are deficient.
8. Deterioration of reserve samples are not investigated
9. Lack of scientifically sound sampling plan for inprocess and finished drug product testing to show samples are representative of the whole batch; specific time points of withdrawal of samples are not documented. Method verification for bioburden, bacterial endotoxins, sterility testing of in process samples is lacking.
10. Procedures for receipt, sampling, approval of drug product components are lacking; do not record quantity sampled for chemical, microbial analysis and retention samples

Meanwhile following another USFDA inspection in Jan – Feb 2024 at Eugia facility in India at Pashamylaram, Aurobindo has halted production / distribution in certain lines. The inspection was closed with nine (9) observations. In a letter to stock exchanges, Aurobindo stated that it has started working with the agency to complete remediation of the issues and restart production at the earliest.

USFDA 483