The non-scheduled FDA visit lasted three days and concluded on Wednesday June 8th. There were no verbal or written observations and thus no 483 form was issued.
The inspection included a review of various documentation, including validation, e-records, and audits. Documents requested covered deviation, change control, data integrity and training.
According to Christi Gimber, Director of Quality at Almac Clinical Services, the inspector commented that the company is “doing GXP training the way it should be done and was very impressed with the program and the variety of topics covered.”
Almac told us "this was a routine, unannounced inspection," which was "successfully hosted without interruption to operational activities."
The company is inspected annually by the NC Department of Agriculture and to date has not been issued findings.
"The NC Board of Pharmacy inspected the Durham facility in 2015 and the DEA inspected in 2014," said a company representative. Neither of these resulted in observations issued to Almac.
"When considering this FDA inspection, Almac found it to be extremely thorough and is delighted that it resulted in no findings. The scope encompassed the review and assessment of an extensive range of documentation and extended to include electronic checks to challenge data integrity. The inspection was in line with a similar FDA inspection of our Craigavon facilities in February this year."
When asked about data integrity issues, Almac commented that it "ensures the integrity of both electronic and paper records through robust policies, procedures and processes."
Additionally, data controls are employed and integrated into the Quality Management System. "These controls deemed fundamental, are embedded throughout the business, embraced within our culture and are rigorously challenged during Validation, Self-Inspection and customer audits," added a representative.