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By Ruma Dubey

There was so much hype and hoopla built around the US FDA inspection of Sun Pharma’s Halol plant. This week, it seemed as though the entire pharma sector future hinged on this FDA verdict and today afternoon, the news was finally out.

The US FDA conducted a Good Manufacturing Practices (GMP) inspection of Sun Pharma’s Halol facility (Gujarat, India) from February 12-23, 2018. At the conclusion of the inspection, the agency issued a Form 483, with three observations. The company is preparing the response to the observations, which will be submitted to the US FDA within 15 business days. Last time , there were six observations.

There is no doubt that with Indian pharma companies exporting big time to USA, the role of FDA has gained a lot of significance and what it “observes” has far reaching consequences on the company and its stakeholders.

Thus we end the week with a quick learning for future reference on the various FDA warning letters and Forms.

This big question that dogs every layman is – what is this Form 483? This is a form of inspection  of the factory, in which the observations or findings of the inspection are noted down. Observations placed on a 483 are the opinion of the FDA investigator and may be subject to review by other FDA personnel.

All goods exported to the USA need to follow the current Good Manufacturing Practices (cGMP) and if there is any deviation from this, it is noted down on the Form 483. It does not give suggestions, merely a clinical inspection of what was not right.

This week Natco came out smelling of roses as the FDA, on completion of its inspection of its Active Pharmaceutical Ingredient (API) facility in Mekaguda Village, near Hyderabad, resulted in zero observations (no form 483 issued). 

Sometimes, there is talk of an “EIR” being issued. This refers to Establishment Inspection Report (EIR) which specifies whether action is required to be taken.

The response to the Form 483 is usually to be given in 15 days working, explaining the reason for the shortcomings and how it plans to correct it. This has to be taken seriously because if the 15 days deadline is missed, the company could end up getting the dreaded “warning letter.’

Getting a warning letter is more serious than a Form 483 as it means senior FDA officials have reviewed the observations and see that a serious violation may exist. The company has to reply, in writing, within a time line as prescribed (usually 15 days) or request an extension and provide justification for request.

In the case of Lupin, last April, it had received the Form 483for its Goa and Indore units and then in Nov, both the units were issued a warning letter. This impacted drug approvals to USA and it also reported a 65% drop in Q3FY18 net profit. The company has undertaken remedial work at the two plants and hopes to complete all work by June 2018 but will be able to fully close out the warning letter only by end of FY19.

And if a company fails to successfully close out the observations mentioned in the warning letter, an import alert is issued – either for the product or for the entire factory. The most serious action is suspension or cancellation of manufacturing license.

Divi’s Labs went through an import alert in March’17 for its unit in Vishakhapatnam. It first closed out the warning letter in July and then the import alert was lifted in November.

So yes, the FDA observations, EIRs, warnings letters and import alerts, all are very very important as we become a smaller and flatter world. And now you have the entire FDA jargon decoded.

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