Oread Biosafety Center Faces FDA Inspection Issues in 1999

Strategic Insights -

The Oread Biosafety Center, a pharmaceutical firm in Farmington, CT, faced issues during an FDA inspection in February 1999. Investigator Anthony Warchut of the New England District Office found several problems related to Standard Operating Procedures (SOPs) for non-clinical lab operations. The firm's lab operation was acquired from Ciba-Geigy in 1995 and had commenced GLP studies the following year. Warchut noted changes to study protocols for unnamed entities, but the FDA purged much of the detail from the inspection documents. The inspection resulted in a 483, but no warning letters were issued.

Key Takeaways:

  • Oread Biosafety Center faced FDA inspection issues related to SOPs for non-clinical lab operations in February 1999.
  • The firm had no procedures directing study directors to include correspondence with sponsors regarding study events and protocol amendments to the records.
  • Dr. Richard Pfeifer, Ph.D., senior study director for toxicology, maintained such correspondence in a separate file, but it was not considered part of the study file.
  • Warchut found that the company had not developed an SOP to ensure study directors were keeping an eye on lab practices.
  • Oread was faulted for lacking procedures specifying critical phases of each type of GLP study to be audited and for not having a timetable for study audits.
  • The firm also had no procedures for the clinical lab to describe the handling of Out-of-Specification (OOS) results for analytical tests.
  • Oread Clinical Lab Manager David Holschlag acknowledged the importance of handling OOS outcomes, but the firm had no standardized approach.

Statistics:

  • The FDA inspection was conducted in February 1999.
  • The Oread Biosafety Center operated several facilities in the U.S., including a drug manufacturing plant, a production lab, and a support services facility.
  • The firm operated in multiple locations, including Farmington, CT, Palo Alto, CA, and Lawrence, KS.
  • The inspection resulted in a 483, but no warning letters were issued.
  • The EIR made no mention of any discussion taking place on some of the issues raised by Warchut.

Sources:

  • FDA inspection report of Oread Biosafety Center, Farmington, CT, 2/16-18, & 22/99, Doc. 108980M, $13.00 plus retrieval.
  • Statement from Oread Biosafety Center, dated January 2, 1999.