FDAnews Drug Daily Bulletin
Pharmaceuticals / Inspections and Audits

Bangladeshi Drugmaker Cited for GMP Non-Compliance

Dec. 14, 2017
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UK health officials imposed a ban on marketing authorizations or clinical trial applications relating to an Acme Laboratories drug production facility in Bangladesh, based on non-compliances observed during an inspection of the company’s Dhaka facility.

The Medicines and Healthcare products Regulatory Agency flagged the facility over quality, data integrity and product sterility issues observed in its first inspection at the site.

The investigators found problems with non-sterile production and evidence of data-integrity and testing issues that brought into question data used to support the release of its antibiotic product Metronidazole.

MHRA noted the facility had not distributed any product to the EU.

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