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1031226

Tarmac Products, Inc. — FEI 1025483

Inspection Details

Classification
Voluntary Action Indicated (VAI) (VAI)
End Date
November 10, 2017
Fiscal Year
2018
Product Type
Drugs
Project Area
Drug Quality Assurance
Location
Miami Gardens, FL (United States)

Facility

Other inspections at this facility

  • 1283730 (VAI Tue Nov 04 2025 00:00:00 GMT+0000 (Coordinated Universal Time))
  • 1175141 (VAI Fri Jul 22 2022 00:00:00 GMT+0000 (Coordinated Universal Time))
  • 1102996 (VAI Fri Sep 27 2019 00:00:00 GMT+0000 (Coordinated Universal Time))
  • 906979 (VAI Thu Jan 08 2015 00:00:00 GMT+0000 (Coordinated Universal Time))
  • 779095 (VAI Wed May 02 2012 00:00:00 GMT+0000 (Coordinated Universal Time))

Recent compliance actions

Citations

IDCFRDescription
104921 CFR 211.22(a)Approve or reject components, products
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
203121 CFR 211.194(a)Complete test data included in records
355921 CFR 211.56(a)Sanitation--buildings not clean, free of infestation
360321 CFR 211.160(b)Scientifically sound laboratory controls
361321 CFR 211.160(b)(4)Establishment of calibration procedures
361621 CFR 211.165(d)Acceptance criteria for sampling & testing