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Today we cover the Form 483 [What is a Form 483?] issued by the US FDA [United States Food and Drug Administration] to Cadila Healthcare’s formulations manufacturing plant at Baddi. On another note, the company is due to announce a dividend of Rs. 3.2 tomorrow. You can catch all the action on the stock at our technical analysis tool SNAP. Also find our detailed coverage of all pharmaceuticals new here.
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.
The US FDA reported three observations to the plant that received the US FDA approval back in 2011 and again in Q4-2016 in the form of an EIR [What is an EIR?]. The oral solid dosage facility [the company had transferred a total of 13 products from Moraiya to Baddi for the US market last year since Moraiya came under the inspection radar and have a $25 million – $30 million plus opportunity] was also the one to receive the ‘Gold Certificate Merit’ in IMEA – India Manufacturing Excellence Awards 2014 instituted by The Economic Times in partnership with Frost & Sullivan.
The company did disclose this inspection details the very next day of the completion of the inspection.
Cadila said that all three observations are related to Pre-Approval Inspection (PAI) for a specific product filed. This product is yet to be manufactured or marketed in the US. The company is already in the process of responding to the PAI observations. Apart from the particular product related observations, there are no observations related to cGMP practices.
Coming back to the Form 483, here are the three observations reported by Nicole E. Knowlton, Investigator and Maria E. Estrella, Investigator.
Here are the observations in detail. These can be our interpretation of the observations in general terms or replicated from the Form 483 if they are too technical in nature:
Manufacturing area to be used in the commercial production of capsules referenced in the application has not been qualified. The construction of the commercial manufacturing line or the opening to the facility and qualification of the area has not been completed.
The existing equipment and the new equipment to be used in the manufacturing process has not been qualified – in other words, the product produced by the not yet validated machinery should be checked to determine whether the process has had any adverse effect on the product or its performance.
Though the explanation to this observation remains heavily redacted , the observation has been made in relation to the manufacturing process wherein for some capsules the production process involved manual intervention and that there was no document to substantiate the flow of the manual operation to be performed.
A capsule with 2 different mgs were required to be manufactured as part of the manufacturing process by the company. However, the inspection team did not find any reference for these made to the US FDA in the production batches or the manufacturing records.
Results obtained for a few batches had a theoretical yield that were not within the set parameters. A deviation investigation was not initiated and there was no documentation in the batch records regarding this discrepancy.
It would be unfair to say that none of these observations are not highly critical in nature. Though the company has disclosed that the inspection was in relation to new products, there is no clear evidence if this would impact the products that have been moved from Moraiya to Baddi for the same poor manufacturing conditions.
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