Apotex Facility in India Flagged for GMP Non-Compliance
An Apotex Research facility in Bangalore, India was cited for non-compliance with GMP requirements after an inspection in November by the UK’s Medicines and Healthcare products Regulatory Agency revealed non-sterile conditions, packaging issues, and inadequate testing.
The MHRA investigators found failures in the firm’s quality controls that resulted in a risk of cross contamination for some products.
The agency withdrew the firm’s GMP certificate and prohibited its products from being supplied to EU markets while the noncompliance statement remains in effect.
In addition, the agency recommended that EU member states consider recalling affected products if they failed swab tests, or to consider a precautionary recall in the absence of swab testing.