Any update on the FDA audit?

(krishna) #131

Officially it may come after 3.30PM

(ashit) #132

BSE announcement

Unit-2 has been inspected by US-FDA from September 11 to September 19, 2017.

This inspection was for full cGMP and verification of all Corrective Actions proposed against the previous Inspection observations. Divi’s Laboratories Limited announces that all previous observations have been confirmed as completed and resolved.

On completion of this inspection, Divi’s Laboratories Limited has received a Form 483 citing six observations which are procedural and the company will be responding to these within the stipulated time.


(chikspat) #133


I am new to pharma companies investing. I hold Laurus labs, they also finished USFDA and WHO audits on 15th. But my question why Laurus labs stock price not reacts and DIVIS labs react to inspections. Is there specific things we need to dig inside. As companies publish audit is finished.

Disc: Invested in Laurus labs so I am interested in how this USFDA inspection things work.

(SS64) #134

Divis lab share price was around 1100-1200 when it got FDA observations and fell to 700+. After Import alert, it fell to 600+
few months back when FDA removed few observations rose to 760+ and then fell to 630+. Now market feels like 1100+ is price it should be so its increasing day by day.

Disc: not invested in Divis now. Sold it when it reached 730+

(Kranthi Kumar) #135

Divi’s Laboratories has been informed by the US-FDA that it will be lifting the Import Alert 66-40 and moving to close out the Warning letter issued to the company’s Unit-II at Visakhapatnam.


Disc: invested

(suhagpatel) #136

The management was quite swift in getting the re-inspection done and making sure that import alert is lifted. I think all this happened in span of 6 months which is quite commendable if you look at other pharma companies who are facing USFDA issues.

Disc: Invested


(Kranthi Kumar) #137

Divi’s received EIR from US FDA for unit II. indeed its a commendable job by the management in resolving the issue swiftly.

"We had earlier informed the Exchanges that the company’s Unit-II at Visakhapatnam was inspected by US-FDA in September, 2017 wherein a Form-483 was issued with 6 observations.

In this regard, we wish to inform you that we have now received an Establishment Inspection Report (EIR) from US-FDA for our Unit-II, as closure of audit by FDA."


(hsay) #138

This worked quite well. Hopefully in a quarter or 2 results would be much better.

(ashit) #139

Divi’s Laboratories announces that its Unit-I at Choutuppal, Telangana State has had an inspection by the US-FDA from 14th May 2018 to 16th May, 2018. This was a general cGMP inspection by the FDA. The inspection has been concluded with no 483 observations


(sheben) #140

ashit, the link provided by you leads to PI industries and not Divis labs

(ashit) #141

Sorry for that

(salil) #142

A good analysis on Laurs . Check this out https://youtu.be/QnOikF30mmM