Claris Lifesciences’ plans to sell its generic sterile injectables business might hit a block as its site in Ahmedabad has recently received an adverse observation letter from the US Food and Drug Administration (FDA). This site underwent FDA inspection between May 4 and 11.
The facility has received a 483 observation letter, from FDA containing five observations. The report adds these observations relate to insufficient procedures, lacunae in sampling, inadequate training and design deficiencies.
Claris manufactures and markets products across multiple delivery systems, markets, and therapeutic segments including anesthesia, blood products, anti-infectives, and plasma volume expanders. A significant majority of these products are generic drugs that are capable of being directly injected into the human body, which are predominantly used in the treatment of critical illnesses.
