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What is USFDA's Form 483?

The US carries out regular inspections at offshore drug making units to ensure quality compliance. In a recent check, the US FDA has issued Form 483 to Sun Pharma Halol unit. Let's demystify Form 483

Sun Pharma | US FDA | public health

Bhaswar Kumar  |  New Delhi 

After a hiatus of two years, the US Food and Drug Administration resumed its onsite inspections of drug manufacturing units outside its borders – including China and India. It has been following this practice to make sure that all the medicines which enter into the country follow the set standards. Most inspections were put on hold in March 2020, when the world was hit by the pandemic.

Indian pharmaceutical companies, on their part, try to adhere to the norms as any departure may hit their export adversely.
In one such inspection at Sun Pharma’s Halol facility this month, the team issued a Form 483. The next morning of May 10, the share price of Sun Pharmaceutical Industries fell over four per cent. So, apparently, the Form 483 and 10 observations made in it were not good for the firm.

The company said that it was preparing a response to the observations, which would be submitted to the USFDA within 15 business days.

The Food and Drug Administration has the responsibility of protecting in the US. In its own words, on the one hand, it does this by ensuring the safety, efficacy, and security of both human and veterinary drugs, biological products, and medical devices. On the other hand, the FDA is responsible for ensuring the safety of the US' food supply. It also deals with cosmetics and products that emit radiation.

According to the USFDA, an FDA Form 483 is issued to the management of the firm being inspected. It is issued at the end of the inspection if the FDA's investigators find that they have observed any conditions that might constitute violations of the Food Drug and Cosmetic Act and related Acts of the US.

Observations are made when the investigators find that the conditions or practices observed indicate that any food items, drugs, devices or cosmetics have been adulterated. Or, if in their judgement, these products are being prepared, packed, or held under conditions in which they might become adulterated or rendered injurious to health.

On their part, the company that has been inspected is supposed to respond to the Form 483 in writing, along with its corrective action plan. The FDA expects that subsequently, the company will implement said plan expeditiously.


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First Published: Thu, May 12 2022. 07:00 IST