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USFDA completes audit for Andhra Pradesh facility of Laurus Labs

As per the USFDA, Form 483 is issued to a firm's management at the conclusion of an inspection when the investigator has observed any conditions that in its judgement may constitute violations of the Food Drug and Cosmetic (FD&C) Act and related Acts.


Devdiscourse News Desk hyderabad India
Updated: 02-11-2018 20:30 IST
USFDA completes audit for Andhra Pradesh facility of Laurus Labs

"The observation is related toa 'procedure'and on Method Validation, which is considered to be very minor," a senior official of the drug maker told PTI. (Image Credit: Reuters)

Laurus Labs Limited, a city-based pharmaceutical company Friday said the US Food and Drug Administration (USFDA) completed the audit for its facility in Andhra Pradesh, with one observation under Form 483.

As per the USFDA, Form 483 is issued to a firm's management at the conclusion of an inspection when the investigator has observed any conditions that in its judgement may constitute violations of the Food Drug and Cosmetic (FD&C) Act and related Acts.

A press release issued by the drug maker said the FDA inspection was done for its Active Pharma Ingredients (API)-Intermediates facility Unit 6 with one observation.

"The observation is related toa 'procedure'and on Method Validation, which is considered to be very minor," a senior official of the drug maker told PTI. The manufacturing facility Unit 6 is located at Atchutapuram in Visakhapatnam, Andhra Pradesh and has 42 reactors with 253 Kilo litres capacity, the release said.

(With inputs from agencies.)

COUNTRY : India

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