Human Cell & Tissue and Cellular & Tissue-based Products (HCT/P)

Inspections Performed in Fiscal Years 1998 to 2006

Inspection Conclusion by Fiscal Year¹

	2003	2004	2005	2006
Inspections Classified NAI *	160	233	217	249
Inspections Classified VAI	53	43	46	96
Inspections Classified OAI	5	7	0	10

Avg. hours per inspection	33.1	33.7	32.2	44.7

*NAI = No Action Indicated, meaning no objectionable conditions or practices were found during the inspection (or the significance of the documented objectionable conditions found does not justify further action).

VAI = Voluntary Action Indicated, meaning objectionable conditions were found and documented but the agency is not prepared to take or recommend regulatory action.

OAI = Official Action Indicated, meaning objectionable conditions were found and regulatory action should be recommended.

(See also, ORA Field Management Directive No. 86, Establishment Inspection Report (EIR) - Inspection Conclusions and District Decisions, June 7, 2007.

QUESTIONS?

Compliance: Hang Dinh - 301-827-6220 or hang.dinh@fda.hhs.gov
Scientific: Dr. Ruth Solomon - 301-827-6107 or ruth.solomonr@fda.hhs.gov

¹Sum of inspection classifications does not equal total number of inspections performed by fiscal year due to data constraints