The inspections were routine and not prompted by a specific concern, Anna Taylor, VP business development, BioPharma Services, told Outsourcing-Pharma.com.
“Each three inspections were separate and un-related,” she said, adding that no observations or 483s were noted during any of the inspections.
The inspections were conducted over a span of two weeks and focused on nine studies, including four bioanalytical validations conducted in support of ANDA and NDA filings.
“Following the close of each audit, the FDA left satisfied with our processes and procedures in Columbia, Missouri and Toronto, Canada,” Taylor said.
“Our last FDA inspections were in Nov 2015 with zero observations, as well. We are extremely pleased with our regulatory track record.”
BioPharma Services Inc. is a full-service contract research organization (CRO) specializing in Phase I/IIa clinical trials as well as bioequivalence trials.