EMA cites US-based Pii for manufacturing violations
- The European Medicines Association will withdraw manufacturing certifications for two U.S. facilities run by Pharmaceutical International Inc. (Pii), after British inspectors found two critical and three major deficiencies at sites in Hunt Valley, Maryland and Cockeysville, Maryland.
- As long as the sites remain non-compliant, Pii will be unable to supply non-critical products to the E.U. The British inspectors also recommended a recall of released product batches, although Pii told FiercePharma that no recall had actually been ordered yet.
- Last month, Swedish regulators cited Capsugel's Bend Research facility in Oregon for violations of good manufacturing practice (GMP), leading to the withdrawal of that site's certification as well.
During inspections in February, regulators from the U.K.'s Medicines and Healthcare Products Regulatory Agency flagged two critical deficiencies, including an organizational failure to minimize cross contamination between hazardous and non-hazardous products.
Inspectors also identified a "gross failure" of the change management, which allowed the use of an unqualified high-pressure liquid chromatography (HPLC) system.
The Cockeysville site produces lyophilisates, small volume liquids, as well as other non-sterile products. Pii's facility in Hunt Valley makes a number of non-sterile products including vaginal tablets.
Pii told FiercePharma that no recalls of any product have occurred and that remediation efforts are currently underway.
While oversight has typically fallen heaviest on production facilities in India and China, the recent citations by EMA member agencies of U.S. sites shows GMP problems can also crop up in the U.S. as well.
- Fierce Pharma U.K. regulator slaps U.S. CMO Pii for GMP lapses