India-based Sun Pharmaceutical Industries Ltd., have faced 11-day long regulatory audit from USFDA, where inspecters have taken a break only on sunday, and expects to end the audit soon.
The USFDA have conducted surprise audits at Sun Pharma's Halol Plant which was started on Sept 8, is still in continuation as on
Sep 19. Close sources said, three USFDA inspectors are still at halol facility
and are focusing on sterile units and microbiology labs.
They also added that USFDA inspectors brifly inspected
manufacturing processes and have focused on the quality control labs. FDA is
concentrating to assess data and records primarily in the HPLC site and micro
data site.
Major issues USFDA noted are the same as seen in previous
cases like incomplete records, concurrent data mismatch, non-maintenance of
records etc. These observations in the past have been treated as adverse
observations. But here in this case everything will clear only once audit
completed.
However a 11 days surprise audit and a list of observations
might raise a Form 483, but it only a assumption at this point of time.
Generally, USFDA issues a form 483 with its observations at
the end of the audit, giving the company a timeframe to rectify any observations.
Sun Pharma’s Halol Plant contributes 25% of company’s profitability.
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