Sun Pharmecutical addresses USFDAs concerns
During this year, the United States Food and Drug Administration conducted inspections and had noticed some manufacturing lapses. The US health regulator had raised concerns over good manufacturing practices (GMP) at its Caraco Pharmaceutical laboratories based in US. As stated by Sun Pharmaceutical, the USFDA concerns were minor observations. The company announced of having addressed the issue and having responded to the USFDA with corrective measures long back.
Earlier in 2009, the USFDA had observed violation of GMP standards and had announced the same. Further, all drugs manufactured at Michigan facility of Caraco. There was a consent decree signed between the company and the USFDA. Last year, USFDA had inspected and further permitted Caraco Pharmaceuticals to resume manufacturing operations of two drugs at the company’s facilities. After the inspection of facilities and the company’s corrective actions, the USFDA found Coraco to be compliant with the consent decree. Following this, the health regulator had permitted to resume manufacturing and packaging operations at its Michigan facility.
