fda-inspection-records

FDA inspections of firms in Gaithersburg, MD

38 firms in Gaithersburg were inspected by the FDA between fiscal years 2009 and 2026. Their most serious classification on file: 18 NAI, 15 VAI, 5 OAI. Main product types: Food/Cosmetics (15), Biologics (9), Devices (8).

FirmProduct typesInspectionsLatest inspection483 observations posted
2C
FEI 3012603861
Food/Cosmetics3Sep 3, 2026 · NAI—
Adventist Healthcare IRB
FEI 3003250672
Devices; Drugs2Mar 29, 2022 · NAI1
Akan Biosciences Inc
FEI 3017871874
Biologics1Sep 30, 2022 · OAI9
Albert Uster Imports, Inc.
FEI 1120470
Food/Cosmetics4Jan 8, 2013 · NAI—
ALTIMMUNE, INC.
FEI 3014744390
Biologics1May 25, 2021 · NAI—
American National Red Cross
FEI 1000305466
Biologics2Nov 16, 2011 · NAI—
AstraZeneca Pharmaceuticals LP
FEI 1000198729
Drugs15Jan 14, 2026 · NAI6
Aventine Hill Gourmet LLC
FEI 3007903277
Food/Cosmetics1Nov 1, 2010 · NAI—
Charlie Chiang's, Inc.
FEI 3003732339
Food/Cosmetics2Nov 2, 2011 · VAI6
Clongen Laboratories LLC
FEI 3006579817
Biologics1Oct 17, 2012 · NAI—
Delmar Deli Provisions, LLC
FEI 3010999182
Food/Cosmetics2Jan 24, 2020 · NAI—
Dexall Biomedical Labs, Inc.
FEI 1121520
Devices1Oct 25, 2010 · NAI—
Drinkmore Delivery Inc.
FEI 3003734003
Food/Cosmetics5Dec 4, 2018 · NAI—
EMERGENT BIOSOLUTIONS, INC.
FEI 3012830614
Drugs1Sep 2, 2022 · NAI—
GCDMV LLC
FEI 3017995192
Food/Cosmetics2Jul 21, 2025 · NAI6
Human Biosciences, Inc.
FEI 3008770963
Devices5Feb 15, 2022 · VAI16
JDKA, LLC
FEI 3003732300
Food/Cosmetics1Jun 17, 2010 · NAI—
Laura Tonnetti, Ph.D.
FEI 3040334425
Biologics1Nov 21, 2025 · NAI—
Leadiant Biosciences, Inc.
FEI 3013308601
Drugs1Jul 8, 2021 · VAI1
LKC Technologies, Inc.
FEI 1119189
Devices3Mar 29, 2018 · VAI13
Maiden Biosciences
FEI 3012973796
Devices2Nov 28, 2022 · VAI2
Master Sales LLC
FEI 3013931359
Tobacco2Nov 21, 2024 · VAI—
Mr. Omelette Papa's Foods
FEI 3013520717
Food/Cosmetics3Apr 21, 2023 · NAI—
Novavax, Inc.
FEI 3011712917
Biologics1Jul 8, 2022 · NAI—
Pepperidge Farm Gaithersburg, MD Combo Depot
FEI 3003710681
Food/Cosmetics1Sep 23, 2011 · NAI—
PERUVIAN USA DISTRIBUTION LLC
FEI 3015147117
Food/Cosmetics1May 5, 2025 · NAI—
Robert E. Litman, M.D.
FEI 3005473403
Drugs3Mar 4, 2025 · NAI1
Roberts Oxygen Company Inc
FEI 1150053
Drugs; Veterinary3Dec 12, 2019 · VAI1
Rowny Systems, Inc.
FEI 3009768528
Biologics; Devices3Jun 17, 2022 · VAI13
Sabouya International Foods Llc
FEI 3008960062
Food/Cosmetics3Oct 31, 2023 · VAI2
Saint-Gobain Performance Plastics Coprporation
FEI 1122024
Devices1Apr 27, 2012 · NAI—
Sigma-Tau Pharmaceuticals, Inc.
FEI 2245635
Drugs4Jan 25, 2013 · NAI2
Smithers Pharmaceutical Development Services
FEI 3032201947
Drugs1Dec 13, 2024 · NAI—
Susan L. Stramer, PhD
FEI 3011714877
Biologics2Jan 24, 2024 · NAI—
Sushi USA Inc.
FEI 3008967695
Food/Cosmetics1Mar 22, 2013 · OAI3
The American National Red Cross Diagnostic Manufacturing Division
FEI 1177732
Biologics; Devices8Jul 10, 2026 · NAI5
Vace, Inc.
FEI 3001237843
Food/Cosmetics3Oct 3, 2019 · VAI11
Whatsa Bagel, Inc.
FEI 3004953396
Food/Cosmetics6Mar 15, 2019 · NAI17

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.