Thermo Scientific's main manufacturing site in Basingstoke, Hampshire, UK has recently had a successful routine audit by the U.S. Food and Drug Administration(FDA).
Although the role of the FDA is to protect the health of U.S. citizens, many other countries worldwide (such as those in the Far East and Latin America) regard FDA approval as the gold standard and their official approval of Thermo Scientific's quality systems means that customers have great confidence in Thermo Scientific products.
"FDA inspections are rigorous, even though ours was what they call a 'routine' audit, which means it wasn't prompted by anything", said Richard Huggins, Quality Manager for the Thermo Scientific Group, "We received four weeks written notice of the audit and the FDA inspector then spent four days with us, reviewing and assessing our systems."
The FDA split the audit into four areas of concern: Management Control,Design Control, Process Control and CAPA (Corrective Action/Preventative Action). The investigator paid particular attention to antimicrobial susceptibility discs and diagnostic reagents (DRs), which the FDA categorises as high-risk products. He spent some time with quality control procedures in production departments, in the assays laboratory and closely examined the DR trials. "The fact that staff were able to provide all the paperwork and documentation that was required greatly contributed to the success in satisfying the audit's stringent requirements", Richard stressed.