WARNING LETTER ISSUED TO PUERTO RICO UNIT OF PATHEON
Canadian drugmaker Patheon's $350 million acquisition of Puerto Rico-based contract manufacturer Mova Pharmaceutical, announced late last year, could soon get a lot more expensive.
Patheon announced recently that CEPH International, a Mova subsidiary, has received an FDA warning letter for violating the agency's current good manufacturing practice requirements. The warning letter, which has yet to be released by the FDA, stemmed from an April inspection of CEPH's Carolina, Puerto Rico, manufacturing plant. FDA investigators identified several problems at the facility, including variations in assay, fill-weight, content uniformity and issues related to the manufacture of an oral powder for suspension, Patheon said.
In response to the FDA's action, Patheon said it is taking immediate action to address the concerns raised by the FDA, and a senior team of Patheon specialists will be working closely with CEPH management. Among other steps, Patheon has outfitted the plant with new equipment, which is currently being validated.
Patheon acquired Mova last December for $137 million in cash and approximately $213 million in stock and debt. In addition to the CEPH plant in Carolina, Mova operates facilities in Cauguas and Manati, Puerto Rico.