The US health regulator has warned Sun Pharma it may withhold approval of new drug applications and extend an import ban at its Karkhadi unit in Gujarat if violations of manufacturing norms at the facility are not corrected.
The US Food and Drug Administration said there were reasons to suggest a general lack of reliability and accuracy of data, including missing fundamental raw data, unacceptable data handling practice and inadequate investigation into 'the pervasive practice of deleting (raw) files'.
"Until all corrections have been completed and FDA has confirmed corrections of the violations and deviations and your firm's compliance with CGMP (current good manufacturing practice), FDA may withhold approval of any new applications or supplements listing your firm as a drug product or an API manufacturer," USFDA said.
In addition, failure to correct the violations and deviations may result in FDA continuing to refuse admission of articles manufactured at Karkhadi into the US, it said.
The warning letter was shot off after the USFDA conducted a review of Sun Pharma's initial response to the issues raised during inspection of the facility in November last year.
"...It lacks sufficient corrective actions. We also acknowledge receipt of your firm's additional correspondence dated January 28, 2014, and March 11, 2014," the USFDA said.
In March this year, the health regulator had banned the import of drugs from the Karkhadi facility for violation of manufacturing norms.
USFDA said its investigators observed specific deviations during the inspection of the API manufacturing facility, including "failure to ensure that laboratory records included complete data derived from all tests necessary to ensure compliance with established specifications and standards."
The health regulator pointed out "failure to assign and identify raw materials with a distinctive code, batch, or receipt number, and to identify the disposition of materials" at the Kharkhadi facility.
Mumbai-based Sun Pharma's Karkhadi facility manufactures antibiotics and active pharmaceutical ingredients (APIs). The company, which is acquiring Ranbaxy Laboratories, has 10 manufacturing sites in India.
Sun Pharma shares closed at Rs 587.30 on the BSE, up 0.63 per cent.
