The U.S. drug regulator has flagged quality control and procedural lapses at Cipla Ltd.'s Indore facility in a pre-approval inspection.
The U.S. Food and Drug Administration had on July 1 conducted a pre-approval inspection at Cipla's drug manufacturing facility at Indore Special Economic Zone in Pithampur, Madhya Pradesh, the company had said in a July 4 exchange filing.
“The company has received two observations on FDA Form 483 with respect to ANDA filed for the product to be manufactured at the said plant. There is no data integrity observation,” it had said in the filing.
An FDA Form 483 is issued when investigators have observed any condition that in their judgment may constitute violation of Food Drug and Cosmetic Act and related Acts.
A pre-approval inspection, according to the U.S. FDA, is performed to assess if the manufacturer named in the drug application is capable of manufacturing and submitting data related to the said drug in an accurate and complete manner.
BQ Prime has obtained a copy of the observations from the FDA.
These are:
Equipment and utensils were not cleaned at appropriate intervals to prevent contamination that would alter the quality and safety of the product. It was observed that raw data used for surface calculations of equipment was not maintained and accordingly, there was no evidence that the swab samples were actually analysed.
The samples taken of drug products for determining conformation to written specifications to establish drug stability were not properly identified. This may indicate a deviation from the stability program protocol to be followed.
Cipla has yet to respond to BQ Prime's emailed queries on the implications of the observations, the revenue contribution of the facility, and impact on future approvals and launches. The company is also yet to comment on the steps been taken to address these issues and the expected timelines.
Cipla shares were trading 0.24% higher as of 1:21 p.m. compared with a 0.11 decline in the benchmark Nifty 50.
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