Frank Wackes

FDA Investigator Report

Designation: CONSUMER SAFETY OFFICER

Duty Station: Silver Spring MD 20993-0002

Organizations: DHHS FDA CDER OMPT CDER OPQ OPF DIA IABII

Total Inspections: 7

Total 483s Issued: 5

Total Warning Letters Issued: 1

Inspection Details

Longest Inspection: 33 days

Shortest Inspection: 5 days

Average Length of Inspection: 15.9 days

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Recent Inspections

DateCompanyCityCountryFEI Number483
2017-03-24Meridian Medical Technologies, LLC a Subsidiary of Kindeva Drug Delivery, L.P.Saint LouisUnited States1950222
2017-03-10Sigma-Aldrich Mfg LLCSaint LouisUnited States1937990
2017-01-20Nephron Sterile Compounding Center LLCWest ColumbiaUnited States3011158388
2016-12-01Kimball Electronics Indianapolis Inc.IndianapolisUnited States3004598644
2016-07-01GP Grenzach Produktions GmbHGrenzach-WyhlenGermany3006308309
2016-05-27Halo Pharmaceutical, Inc. d/b/a Cambrex WhippanyWhippanyUnited States2211084
2015-11-16Woodstock Sterile Solutions IncWoodstockUnited States1419377

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Download 483s and EIRs for Frank Wackes

Co-Inspectors

NameInspectionsLast Inspection
Kshitij A Patkar12017
Phillip M Pontikos12017
John C Mcmichael12017
Rick L Friedman12017
Zedong Dong12017
Kellia N Hicks12017
Rita K Kabaso12017
Michele L Obert12017
Bonita S Chester12017
Larry K Hampton12017
Michele Perry-Williams12017
Haitao Li12016
Paul A Bonneau12016
Debara R Reese12016
Robert M Barbosa12016
Helen Verdel12016
Jonathan G Swoboda12015
Christopher D Leach12015

Active Locations

Year-wise Inspection Count