The inspection was conducted between January 20 and January 24, 2020.
Biocon share price added 2 percent intraday on May 8 after the company received EIR from the USFDA.
The company has received the Establishment Inspection Report (EIR) from the US Food and Drug Administration (FDA) for the pre-approval and GMP inspection of its Small Molecules API Manufacturing facility at Biocon Park SEZ, Bommansandra, Bengaluru.
The inspection was conducted between January 20 and January 24, 2020.
At the conclusion of the inspection, the agency had issued a Form 483, with five observations, which are being addressed by the company.
The EIR has been closed with a VAI classification for the observations.
We remain committed to global standards of quality and compliance, said company spokesperson.
At 09:51 hrs Biocon was quoting at Rs 353.25, up Rs 3.60, or 1.03 percent on the BSE.Moneycontrol Ready Reckoner
Now that payment deadlines have been relaxed due to COVID-19, the Moneycontrol Ready Reckoner will help keep your date with insurance premiums, tax-saving investments and EMIs, among others.
Special Offer: Subscribe to Moneycontrol PRO’s annual plan for ₹1/- per day for the first year and claim exclusive benefits worth ₹20,000. Coupon code: PRO365
First Published on May 8, 2020 10:06 am
