Home / Inspections / 1264815

1264815

Acuity Specialty Products, Inc. — FEI 3006317477

Inspection Details

Classification
Official Action Indicated (OAI) (OAI)
End Date
March 14, 2025
Fiscal Year
2025
Product Type
Drugs
Project Area
Drug Quality Assurance
Location
Chambersburg, PA (United States)

Facility

Other inspections at this facility

  • 1065448 (VAI Thu Sep 13 2018 00:00:00 GMT+0000 (Coordinated Universal Time))
  • 941080 (VAI Fri Sep 11 2015 00:00:00 GMT+0000 (Coordinated Universal Time))
  • 784078 (VAI Tue Jun 05 2012 00:00:00 GMT+0000 (Coordinated Universal Time))
  • 635530 (VAI Fri Dec 18 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
121521 CFR 211.67(b)Written procedures not established/followed
127421 CFR 211.68(a)Calibration/Inspection/Checking not done
136121 CFR 211.100(a)Absence of Written Procedures
191221 CFR 211.166(a)Written program not followed
202721 CFR 211.192Investigations of discrepancies, failures
356721 CFR 211.84(d)(2)Component identification test
360321 CFR 211.160(b)Scientifically sound laboratory controls
439121 CFR 211.180(e)(2)Items to cover on annual reviews