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1099983

Tec Laboratories, Inc. — FEI 3021059

Inspection Details

Classification
Official Action Indicated (OAI) (OAI)
End Date
August 9, 2019
Fiscal Year
2019
Product Type
Drugs
Project Area
Drug Quality Assurance
Location
Albany, OR (United States)

Facility

Other inspections at this facility

  • 1172658 (NAI Thu May 19 2022 00:00:00 GMT+0000 (Coordinated Universal Time))
  • 941729 (VAI Thu Aug 20 2015 00:00:00 GMT+0000 (Coordinated Universal Time))
  • 819220 (NAI Thu Feb 07 2013 00:00:00 GMT+0000 (Coordinated Universal Time))
  • 753058 (VAI Fri Oct 28 2011 00:00:00 GMT+0000 (Coordinated Universal Time))
  • 626811 (OAI Fri Oct 30 2009 00:00:00 GMT+0000 (Coordinated Universal Time))

Recent compliance actions

Citations

IDCFRDescription
110521 CFR 211.22(d)Procedures not in writing, fully followed
121321 CFR 211.67(a)Cleaning / Sanitizing / Maintenance
121521 CFR 211.67(b)Written procedures not established/followed
126321 CFR 211.68(b)Computer control of master formula records
135821 CFR 211.100(b)SOPs not followed / documented
141321 CFR 211.42(c)(5)Mfg / Processing Operations Area
357121 CFR 211.100(a)Changes to Procedures Not Reviewed, Approved