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17 Mar 2016

Emcure Pharmaceuticals gets USFDA warning letter

The US Food and Drug Administration (USFDA) has issued a warning letter to Emcure Pharmaceuticals for violating current good manufacturing practice norms at its Pune-based plant. The significant violations included non-adherence to appropriate written procedures, poor sterilization practices and unreliable environmental and personnel monitoring.

Detailed observations mentioned as follows –

Operators crawled on the floor on their hands and knees under the filling line during routine aseptic filling operation activities.

Besides, operators opened barrier to adjust or remove vials from the line with bare hands, instead of wearing restricted access barrier systems,

The facility design may represent an additional contamination risk to the products it manufactures.

Furthermore, data falsification and manipulation, and your reliance on incomplete records to release product to the market, are repeat violations,” the US health regulator said.

Until all corrections have been completed and FDA has confirmed corrections of the violations and the firm’s compliance with CGMP, FDA may withhold approval of any new applications or supplements, the USFDA said.

In addition, your failure to correct these violations may result in FDA continuing to refuse admission of articles manufactured at Emcure Pharmaceuticals’ Pune plant into the US, it added. The FDA issued the letter on March 3, and has given the company 15 days to respond. The company could not be reached for comments over the FDA letter.

Review:

What is 483 observations?

 

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