MHRA Demands Recall, Withdrawal of GMP Certificate for Pharmaceutics International

British authorities are ordering a U.S. manufacturer to recall drug batches, suspend clinical trials and cease distribution after an inspection uncovered critical GMP violations.

The UK’s Medicines and Healthcare products Regulatory Agency wants to withdraw Pharmaceutics International’s GMP certificate from one of the company’s two side-by-side facilities located in Hunt Valley, Md.

The same-day inspection of the two facilities uncovered a total of four critical GMP violations and six major ones at the combined site.