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FDA Inspection 993515 — AMO Puerto Rico Manufacturing, Inc.

AMO Puerto Rico Manufacturing, Inc. — FEI 2648035

The FDA completed an inspection of AMO Puerto Rico Manufacturing, Inc. on November 28, 2016 in Anasco, PR. The inspection was classified VAI (Voluntary Action Indicated — objectionable conditions were found but do not meet the threshold for regulatory action). Product area: Devices.

Inspection Details

Classification
Voluntary Action Indicated (VAI) (VAI)
End Date
November 28, 2016
Fiscal Year
2017
Product Type
Devices
Project Area
Compliance: Devices
Location
Anasco, PR (United States)

Facility

Other inspections at this facility

  • 1070384 (NAI Fri Oct 05 2018 00:00:00 GMT+0000 (Coordinated Universal Time))
  • 946268 (VAI Fri Oct 16 2015 00:00:00 GMT+0000 (Coordinated Universal Time))
  • 871503 (VAI Wed Mar 26 2014 00:00:00 GMT+0000 (Coordinated Universal Time))
  • 822723 (VAI Thu Feb 28 2013 00:00:00 GMT+0000 (Coordinated Universal Time))
  • 670573 (VAI Tue Jun 29 2010 00:00:00 GMT+0000 (Coordinated Universal Time))

FDA data resources