The proposed ban follows an inspection of the contract manufacturer’s manufacturing sites in Hunt Valley and Cockeysville, Maryland by the UK’s MHRA in February which uncovered a number of deviations from GMP.
The European Medicines Agency (EMA) began assessing drugs made at the sites in July, and last week the Committee for Medicinal Products for Human Use (CHMP) recommended a ban on all medicines made by Pii except for Ammonaps (sodium phenylbutyrate) which it considered to be critical for public health.
“The manufacturing site Pharmaceutics International Inc. in the United States which makes a number of medicines has been found to have several shortcomings in its good manufacturing practice,” the EMA wrote on Friday.
“The manufacturing site had insufficient measures in place to reduce the risk that traces of one medicine could be transferred to another (cross-contamination), as well as problems with the way data were generated and checked and deficiencies in the systems for ensuring medicines’ quality (quality assurance).”
The Agency added this was a precautionary measure, and “there’s no evidence of harm or lack of effectiveness with any of the medicines” made by Pii.
The original MHRA inspections revealed organisational and technical failures at both sites to minimise the risk of cross-contamination, while inspectors described the use of an unqualified HPLC system and an "unacceptable approach to production equipment qualification" as "a gross failure of change management" at the Hunt Valley site.
Pii did not respond to a request from this publication for comment on the EMA’s decision by the time of going to press.
In perhaps better news, earlier this month a consortium of investors led by Signet Healthcare Partners invested $93m (€83m) into the contract manufacturing organisation (CMO), in exchange for an equity stake in the company.
Pii’s founder and CEO Syed Abidi said at the time the investment “will allow us to better serve our clients and marketing partners and to build a bigger pipeline of products.”