FDA Scrutiny of Alpha Therapeutic Continues Amid Bureaucratic Battles

FDA inspections of Alpha Therapeutic's plasma collection facilities in Seattle, WA, reveal ongoing concerns about donor screening and plasma fractionation, echoing previous issues with contamination and inadequate SOPs. The agency's letter in July 1998 criticizes Alpha's handling of unsuitable units and lack of documentation, while the company disputes FDA's claims, pointing to CBER approval and ABRA guidance.

Key Takeaways:

• Alpha Therapeutic's two plasma collection facilities in Seattle were subject to FDA inspections in May and June 1998, resulting in a warning letter in July 1998.
• The inspections focused on donor screening, handling of unsuitable units, and plasma fractionation, highlighting deficiencies in Alpha's Standard Operating Procedures (SOPs).
• FDA cited Alpha for distributing source plasma for further manufacture despite donors not being screened for high-risk behavior and for diverting unsuitable plasma to in vitro diagnostic (IVD) manufacturing purposes.
• Alpha disputed FDA's claims, arguing that CBER had approved the practices and that the decision to divert questionable plasma for use in diagnostic reagents was a cautious approach to injectables.
• The company's response to the warning letter emphasized prevention and corporate management involvement in retraining staff, revising SOPs, and implementing new procedures.
• Alpha submitted revised procedures to CBER for review and quarantined all units designated for in vitro use, but further FDA scrutiny raised additional concerns, including inadequate SOPs and failure to document screening errors.

Statistics:

• Two Alpha Therapeutic plasma collection facilities in Seattle, WA, were inspected by FDA in May and June 1998.
• FDA issued a warning letter to Alpha in July 1998, citing deficiencies in donor screening and plasma fractionation.
• Alpha disputed FDA's claims, pointing to CBER approval and ABRA guidance for their practices.
• The agency requested an update on promised SOP revisions and a progress report on an audit of product releases at all facilities.
• Alpha submitted revised procedures to CBER for review and quarantined all units designated for in vitro use.
• Two August 1997 shipments of plasma were "still being researched" for potential contamination.

Sources:

• FDA warning letter to Alpha Therapeutic, Seattle, WA, July 1998 (Doc. 6846W).
• FDA 483 inspection reports, May and June 1998 (Docs. 108646M, 108647M).
• ABRA (American Blood Resources Association) guidelines for donor screening.
• CBER (Center for Biologics Evaluation and Research) approval documentation for Alpha's plasma fractionation procedures.
• Alpha Therapeutic's corporate responses to FDA warnings and inspections.