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921337

Oral Biotech, LLC — FEI 3003422682

Inspection Details

Classification
Voluntary Action Indicated (VAI) (VAI)
End Date
April 2, 2015
Fiscal Year
2015
Product Type
Devices
Project Area
Compliance: Devices
Location
Albany, OR (United States)

Facility

Other inspections at this facility

  • 1252504 (VAI Thu Oct 24 2024 00:00:00 GMT+0000 (Coordinated Universal Time))
  • 1181597 (NAI Tue Sep 27 2022 00:00:00 GMT+0000 (Coordinated Universal Time))
  • 1056597 (VAI Fri Jun 22 2018 00:00:00 GMT+0000 (Coordinated Universal Time))
  • 746170 (NAI Tue Aug 16 2011 00:00:00 GMT+0000 (Coordinated Universal Time))

Citations

IDCFRDescription
1472221 CFR 820.40Procedures not adequately established or maintained
328221 CFR 820.90(a)Nonconforming product, Lack of or inadequate procedures
333121 CFR 820.181DMR - not or inadequately maintained
341521 CFR 820.22Quality Audit/Reaudit - conducted
366821 CFR 820.20(c)Management review dates