USFDA inspects Panacea Biotec's wholly-owned arm at Baddi; stock plunges ~2%

10 Jun 2022 , 02:25 PM

Panacea Biotec Limited informed that the United States Food and Drug Administration USFDA conducted an inspection of the Company’s material wholly-owned subsidiary, Panacea Biotec Pharma Limited at Baddi, Himachal Pradesh, India. The inspection was carried out between May 30, 2022, and June 08, 2022.

On completion of the inspection, PBPL was issued an ‘FDA Form 483’ with eight (8) observations that are related to improvements in existing procedures and are addressable.

PBPL is required to respond to the US FDA within the stipulated time period and work closely with USFDA to close the said observations and the closure of the Warning Letter issued by the USFDA earlier on September 24, 2020.

The company stated in its filing, “Panacea is committed to patient safety and quality and takes quality and compliance matters seriously and stands by our commitment to fully comply with the CGMP quality standards.

Panacea Biotec is currently trading at Rs145.15 down by Rs2.85 or 1.93% from its previous closing of Rs148 on the BSE. The scrip touched intraday high and low of Rs155 and Rs145.10 respectively.