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1087246

Alden Medical LLC — FEI 1221361

Inspection Details

Classification
Voluntary Action Indicated (VAI) (VAI)
End Date
April 23, 2019
Fiscal Year
2019
Product Type
Drugs
Project Area
Drug Quality Assurance
Location
W Springfield, MA (United States)

Facility

Other inspections at this facility

  • 1080433 (NAI Tue Dec 18 2018 00:00:00 GMT+0000 (Coordinated Universal Time))
  • 833790 (NAI Fri May 17 2013 00:00:00 GMT+0000 (Coordinated Universal Time))
  • 681308 (VAI Tue Sep 21 2010 00:00:00 GMT+0000 (Coordinated Universal Time))

Citations

IDCFRDescription
111221 CFR 211.25(a)Training--operations, GMPs, written procedures
117721 CFR 211.63Equipment Design, Size and Location
121321 CFR 211.67(a)Cleaning / Sanitizing / Maintenance
139521 CFR 211.103Actual vs. theoretical yields not determined
181821 CFR 211.84(c)(2)Appropriate Opening of Component Containers
185121 CFR 211.84(e)Rejecting When Specifications Not Met
194221 CFR 211.180(e)Records reviewed annually
358521 CFR 211.110(a)Control procedures to monitor and validate performance
360321 CFR 211.160(b)Scientifically sound laboratory controls
361321 CFR 211.160(b)(4)Establishment of calibration procedures
362321 CFR 211.170(a)Active ingredient retained sample kept
363221 CFR 211.170(b)Annual visual exams of drug products
431421 CFR 211.84(d)(2)Reports of Analysis (Components)