Ipca Laboratories cited for quality issues at India facility that produces API
The FDA identified several quality issues at a plant in India owned by Ipca Laboratories that makes active pharmaceutical ingredients.
In the seven-page inspection report, the FDA cited several issues during an inspection at a facility in Piparia, India, that took place between April 18 to 26.
The inspection found that the site had not properly investigated several batches of products, shared results without getting to the root of issues in some cases, and had not properly followed the investigational procedure in other cases.
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