The UK’s Medicines and Healthcare Products Regulatory Agency (MHRA) made the recommendation in a EudraGMDP notice last week, also confirming it has withdrawn Evertogen‘s certificate of good manufacturing practices (GMP) compliance.
The MHRA said, “A desktop inspection identified a critical deficiency in regard to the integrity of data, QC laboratory capability, cross contamination, a lack of senior management control and a failure of the quality system.
“This was confirmed following an on-site inspection. Manufacturing personnel changed the method of manufacture without approval. Rejected in-process material was added to subsequent batches and excess discarded at packaging.”
The UK regulator also raised concerns about “cross contamination events,” in which “include rogue tablets, capsules, package inserts and blisters in cartons” for one product were found in other products also made at the site.
In addition, the MHRA said QC personnel had reused sample data for unrelated batches, missed time points during stability testing and based risk assessments on pre-existing data.
The Mahabubnagar plant makes tablet and capsule based pharmaceutical products. Regulators in India, Canada, Ukraine, Australia and Kazakhstan have approved it to supply drugs according to Evertogen’s website.
Evertogen did not respond to a request for comment.