Shares of Granules India Ltd. fell as much as 3% on Wednesday, March 5, after the United States Food and Drug Administration (USFDA) made the warning letter issued to the company’s Gagillapur unit public. The warning letter was issued on February 26, which was informed to the exchanges by Granules on February 27.The warning letter highlights data integrity, quality and contamination issues and analysts do not expect a faster clearance for the plant.
These are the three key points highlighted in the warning letter:
- Failed to establish and follow adequate written procedures for cleaning and maintenance of equipment. Significant contamination found as well.
- Failed to maintain buildings in a good state of repair. The warning letter also said that birds, small animals and insects were entering the plant. Additionally, bird droppings and feathers were also found inside the plant.
- Failure to calibrate, inspect or check manufacturing equipment as per a written program, risking quality of the drugs.
Inspectors have also found torn CGMP records, including balance sheet printouts and testing data in 15 waste bags, raising data integrity concerns.Granules’ Gagillapur facility contributes to 70% of the company’s overall revenue.
The company had mentioned in its release on February 27 that as a result of its warning letter, pending product approvals from this facility may be delayed.
Analysts believe that at least 10 pending approvals may be delayed due to this warning letter.
Shares of Granules India are trading 2.6% lower on Wednesday at ₹460.
