MHRA finds evidence of data integrity issues at Acme Lab's plant

11-Dec-2017 - Last updated on 11-Dec-2017 at 13:59 GMT

Gettyimages/ Oleksii Liskonih

Related tags European union Regulation

UK regulators have issued Bangladesh-based drug maker The Acme Laboratories Limited a statement of GMP non-compliance after finding a plant inspection.

The Medicines and Healthcare products Regulatory Agency (MHRA) visited the facility in Dhulivita, 40 km north of the capital Dhaka, in August according to a report on the EudraGMDP database.

The inspectors wrote “There was evidence of data integrity issues with GMP documents bringing into question data used to support GMP decisions such as product release,” and issued Acme with a statement of non-compliance.

An MHRA spokeswoman told us "First inspections such as this come about when MHRA receives a new marketing authorisation application or variation to an existing marketing authorisation, proposing to name the site on the authorisation" adding "this was a first inspection, no products have been imported into the EU or UK."

She added that: "With regards to the nature of the issues found, we can advise there was evidence of data integrity issues which then brought into question data used to support product release decisions."

The facility produces solid dosage form versions of the antibiotic metronidazole.

According to the MHRA “The site does not currently have a GMP certificate as this was the first inspection, a full scope Statement of Non Compliance will be issued.”

Acme did not respond to a request for comment.