Exclusive: We Reveal The Observations Made By US FDA’s Inspection Of Sun Pharma’s Halol Facility



True to our promise of keeping a tab on the US FDAs inspection of Sun Pharma’s Halol facility, we are happy to get our hands on the Form 483 issued for the re-inspection conducted against the warning letter of December, 2015 and the initial inspection of September, 2014.

This is not a recommendation to buy or sell the stock. Analyst and family do own some of the positions listed here. Please assume we are biased.


Observation 1:

Field Alert Reports were not submitted within 3 working days of receipt of information concerning bacteriological contamination and significant chemical, physical, or other change or deterioration in a distributed drug product.

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Our understanding signifies Observation 7 and 8 as highly critical. Even if Sun is able to take remediation steps for others observations, a re-inspection would be required so that the FDA has been assured that the plant would no longer have any cGMP issues including product recalls.

Considering FDA’s over arching schedule, this should take at least 6-8 months for handling the remediation.

The stock closed at Rs. 678.40/- which is even lower than what it was in September, 2014 and December, 2015.