FDA seals drug manufacturing firm in Faridabad

Food and Drug Authority of Haryana today raided the premises of a drug manufacturing unit in Faridabad and sealed it as it was found to be allegedly violating provisions of the Drugs and Cosmetics Act.
An FDA team sealed the firm as it was found manufacturing sterile and non-sterile orthopaedic implants, which come under the definition of 'drug', without proper license, an FDA spokesperson said here.
The firm was jointly inspected by the state FDA team along with FDA officials from Central Drugs Standard Control Organisation in 2011 on an application made by it for grant of drugs manufacturing license, he said.

Many shortcomings of serious nature were observed during that inspection and the firm was directed by the State Drugs Controller, Haryana to remove them, he said.
But the firm allegedly did not remove the shortcomings.
During the raid, the firm was found manufacturing sterile orthopaedic implants without maintaining the required clean room conditions which may be harmful for patients, he said.
The FDA team collected samples of sterile orthopaedic implants for test and analysis, besides seizing 23 types of such implants, he said.
An orthopedic implant is a medical device manufactured to replace a missing joint or bone or to support a damaged bone.