The observations relate to the Indian company’s Halol, Gujarat facility, which the US Food and Drug Administration (FDA) inspected between June 3 and June 11 of this year.
Amongst the observations made was the disclosure that the company had begun design activities for an injection product, with the exact product redacted, in August 2012 but the process had only been approved on May 2019.
In addition, the FDA noted that the company “did not have an established device history file that demonstrated conformance to an established design plan.”
Other observations noted that Sun Pharma employees did not follow procedures designed to prevent microbiological contamination of drugs products that were specified as sterile, and environmental monitoring of plates was conducted incorrectly.
The inspector noted at the end of the report that the company ‘promised to correct’ two out of the four observations at the time of inspection.
It is the second time this year that Sun Pharma has received a Form 483 from the US FDA, with the prior instance arising due to one observation noted at a different facility also located in Halol.
The observation was in regard to out-of-specification results of products, and discovered as part of a pre-approval inspection of the facility.
Last month, the company posted its fourth quarter financial results for 2019, where the company reported a growth of 5% over results from the same quarter of the previous year, with net profit rising by 9.3%.
Sun Pharma’s share price, at the time of writing, is down 1.5% on the release of the Form 483.
