Last Updated on October 17, 2024 by The Health Master
Pharma-major Lupin has received seven observations from the USFDA after the latter carried an inspection at the company’s Goa facility in India.
The US health regulator carried the inspection between September 10 to September 18, 2021, and closed with seven observations.
Lupin said that “We are confident of addressing the observations satisfactorily and are committed to be compliant with Good Manufacturing Practice standards across all our facilities.”
At around 10.42 am, Lupin was trading at Rs 939.40 per piece down by 1.2% on Sensex.
The stock has touched an intraday high and low of Rs 941.30 per piece and Rs 913 per piece respectively.
The observations received by the company are as follows:
- Investigations of an unexplained discrepancy did not extend to other drug products that may have been associated with the specific failure or discrepancy.
- In process, materials are not tested for strength and approved or rejected by the quality control unit during the production process.
- Examination and testing of samples did not assure that the drug product and in-process material conformed to specification.
- Establishment of the reliability of component supplier’s report of analysis is deficient in that the test results are not appropriately validated at appropriate intervals.
- The procedures for annual quality standards record evaluation are deficient in that they do not address a review of returned drug product records for each drug product.
- The written stability programme is not followed.
- Access to the storage area for labels and labelling materials is not limited to authorised personnel.
– Inputs from Express Pharma also added
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