fda-inspection-records

FDA inspections of firms in San German, PR

10 firms in San German were inspected by the FDA between fiscal years 2009 and 2026. Their most serious classification on file: 3 NAI, 6 VAI, 1 OAI. Main product types: Biologics (5), Devices (4), Drugs (3).

FirmProduct typesInspectionsLatest inspection483 observations posted
Bio Tech Med Corp.
FEI 3007946244
Biologics5Jan 31, 2020 · NAI3
Biomedica Biological Testing Laboratories
FEI 1000131863
Devices; Drugs2May 18, 2016 · NAI4
Cordis LLC
FEI 3003742446
Devices2Aug 16, 2011 · VAI4
Dulceria Mercado
FEI 3004006280
Food/Cosmetics2Feb 8, 2018 · VAI7
Fenwal International Inc.
FEI 1000222291
Devices3Mar 21, 2016 · NAI—
Hospital De La Concepcion, Inc.
FEI 2676439
Biologics1Oct 17, 2012 · NAI—
OMJ Pharmaceuticals, Inc.
FEI 2627210
Drugs2Sep 27, 2011 · NAI2
Pace Analytical Inc.
FEI 2623531
Biologics; Devices; Drugs7Aug 7, 2025 · VAI5
Puerto Rico Tissue Reserve Foundation, Inc.
FEI 3003491796
Biologics1Feb 27, 2009 · NAI—
Southwest Health Corp.
FEI 3004517274
Biologics6May 19, 2017 · NAI4

Alphabetical order — this site ranks no firm. Inspections from fiscal year 2009 to 2026; the classification is the FDA's (NAI no action indicated, VAI voluntary action indicated, OAI official action indicated). Select a firm for every inspection, the posted Form 483 observations and any compliance action. How to read this.