The company believes that the observations are minor in nature and have been already addressed
Lupin has recently clarified on the observations relating to violation of production norms at its manufacturing facilities at Mandideep, Madhya Pradesh by the US Food and Drug Administration.
As per the company, an audit was carried out at the firm’s Mandideep facility from February 2-19, 2016. As the site has both dosage and API facilities, two separate form 483s were issued with two observations each. One of the observations was repeated in both the forms as it is relevant to both operations.
Lupin believes that these observations are minor in nature and have been already addressed. The outcome of the audit will be voluntary action indicated only and there will be no remediation required, as per the clarification.
“One of the observation which was erroneously quoted relates to use of non-conforming intermediate for making API prior to 2015. This was done based on laboratory trials and scientific rationale that further processing steps were capable of producing desired quality API. All API batches and drug product batches manufactured using such APIs complied with the specifications and hence were released to market. Appropriate corrective and preventative actions were already implemented in 2015 and were verified by the FDA investigator. As an abundant precaution, we have since recalled batches manufactured from this period. There is no material financial impact of the recall,” Lupin mentioned in a regulatory filing.
The company’s Mandideep facility is engaged in the manufacturing of APIs as well as dosage forms which produces sterile and non-sterile pharmaceutical products and mainly caters to the US and Europe markets. It employs over 1,200 people and was established in 1986.
(With inputs from PTI)
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