In regulatory filing to BSE, Ipca Laboratories said US FDA conducted inspection of its formulations manufacturing unit from from August 19 – 23
Ipca Laboratories said the US Food and Drug Administration (FDA) has conducted an inspection of its formulations manufacturing unit in Silvassa and issued three observations. In a regulatory filing to BSE, Ipca Laboratories said the US FDA had conducted the inspection of the its formulations manufacturing unit situated at Piparia (Silvassa) from August 19 – 23.
“At the conclusion of the inspection, the US FDA issued a Form 483 with 3 (three) observations. The company shall be submitting its comprehensive response on these observations to the US FDA within the stipulated time frame,” it added.
The company said it is committed to address these observations promptly.
The US health regulator issues observations by means of Form 483 notifying the company’s management of objectionable conditions at the facility inspected.