FDA Audit Reveals Critical Issues at Abbott Labs Hospital Products Division

In June 1999, a FDA audit at Abbott Labs Hospital Products Division in McPherson, KS, uncovered several critical issues, including problems with the validation of a pentose assay method, insufficient surface sampling, and non-compliance with environmental control requirements.

Key Takeaways:

• The FDA audit, conducted by CBER microbiologist Cynthia Whitmarsh and Team Biologics investigator Sidney Priesmeyer, found several critical issues with Abbott Labs' Hospital Products Division in McPherson, KS.
• The audit cited Abbott for several problems with a pentose assay method, including a lack of documentation of the method's validation and the transfer of technology between Abbott and Lederle.
• The FDA team noted that Abbott's environmental controls were insufficient, with only one set of personnel monitoring samples per day submitted despite multiple instances of ingress and egress during a work day.
• The audit also found that Abbott's procedure for monitoring non-viable particulates was limited to a pair of one-minute samples collected at two locations, which is out of line with filling procedures for aseptic products.
• Priesmeyer noted that Abbott's monitoring plan was limited because it fails to demonstrate whether environmental conditions improve, degrade or remain constant throughout aseptic filling operations.
• Abbott's quality assurance manager, Daniel Proctor, promised to relay the findings to Lederle and to consider the FDA's comments on environmental control requirements.
• The audit cited Abbott for several other problems, including a lack of interlocking doors in a Class 10,000 gowning room and a limited sampling frequency in the system producing water for injection.

Statistics:

• The FDA audit was conducted over a 10-day period in June 1999.
• The audit cited Abbott for a total of 18 issues, including problems with the pentose assay method, insufficient surface sampling, and non-compliance with environmental control requirements.
• Abbott's surface sampling protocol included monitoring of non-viable particulates, which was limited to a pair of one-minute samples collected at two locations.
• The FDA team noted that these practices were out of line with filling procedures for aseptic products, which typically consumed up to seven hours.
• Abbott's monitoring plan was criticized for failing to demonstrate whether environmental conditions improve, degrade or remain constant throughout aseptic filling operations.

Sources:

• Abbott Labs Hospital Products Division, McPherson, KS, CBER FDA's audit of the McPherson, KS, plant operated by Abbott Labs.
• Priesmeyer, S., Whitmarsh, C. (1999). Inspection report of the McPherson, KS, plant operated by Abbott Labs Hospital Products Division.
• FDA documents, June 1999.