Sun Pharmaceutical Industries said that the health regulator of the US issued a Form 483 having 10 observations after the completion of the inspection of their Halol-based manufacturing unit in Gujarat.
According to the USFDA as mentioned in the Hindu, the form is issued to the management of the firm at the inspection’s conclusion after the investigator noticed some conditions in its judgment that may possess the FD&C (Food Drug and Cosmetic) Act and other related acts’ violations.
Halol Sun Pharma facility classified as OAI
In March 2020, it was said that the Halol Facility is an OAI (Official Action Indicated). It was waiting for re-inspection from the US regulation. Because of the travel limitations caused by the pandemic, the process has been delayed. And at present, Form 483 has been issued by USFDA for as many as 10 observations.
Sun Pharma notified the stock exchanges that the USFDA performed a GMP (Good Manufacturing Practices) inspection of the Halol facility of Sun Pharma industries in Gujarat from 26th April to 9th May 2022.
The response time of the inspection
As per the information published in Business Standard, Form 483 was issued at the inspection’s end, having 10 observations. Sun Pharmaceutical Industries is getting prepared to respond to all the observations, and it will be submitted within the next 15 days to the USFDA, according to the company.
The observations need to be promptly addressed, and it has committed to working closely with the USFDA.
According to an analyst’s study based in Mumbai, the OAI status of the company still exists, and therefore form 483 having 10 observations will perform the best. However, the stocks of Sun Pharmaceuticals dropped by 2.74% the last Tuesday.
Sun Pharma’s facility’s contribution
It was further added by the analyst that it is estimated that the Halol facility contributes about 5 to 6% of the turnover of the company at maximum.
Halol is becoming smaller over the years. And there might be some valuable products that are manufactured by the plant. However, new filings are all from Sun Pharma’s other plants. Thus, for the last few years, Sun Pharma’s Halol facility has been on the radar of USFDA as per the information in Business Standard.
According to the company, it has completed every corrective action needed to get the facility back into the right state, and they have been waiting for the USFDA’s re-inspection form.
In 2019’s end, the Halol facility of the company was inspected by the USFDA, and form 483 was issued having 8 observations. After the company submitted its response in 2020’s January, the inspection status was classified by USFDA as OAI.
Sun Pharmaceutical Industries is continuing to make and distribute its products from Halol Facility to the US. However, the OAI status means that the USFDA may not let new approvals from the facility till the status gets changed.
Sun Pharma is putting its best efforts into coping with things and getting them correctly positioned so that it can return to its earlier state.