FDA Form 483 Database

Form 483s

Every Form 483 on record, with its observations, the regulations cited, and the site and investigators behind it.

45

Form 483s

248

Observations

44

Sites

79

Investigators

Category
Year
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45 of 45 Form 483s

Oxalis Labs

Form 483 · April 24, 2026

Solan, India

Human Drugs

3

Observations

Issued by Anastasia M Shields, Karishma G Gopaul

View Form 483

Alcami Carolinas Corporation

Form 483 · April 22, 2026

Charleston, United States

Animal Drugs & Feeds

7

Observations

Issued by Sonya M Edmonds, Steven A Brettler

View Form 483

Silgan Unicep Packaging, LLC

Form 483 · April 2, 2026

Spokane, United States

Human Drugs

8

Observations

Issued by Crystal Monroy, Carolina D Vasquez

View Form 483

Valley Springs Artesian Gold, LLC

Form 483 · February 13, 2026

Portage, United States

Foods & Cosmetics

18

Observations

Issued by Peter T Erlandson

View Form 483

Patheon Italia S.p.A.

Form 483 · February 10, 2026

Monza, Italy

Biologics

1

Observations

Issued by Lewis K Antwi, Peng Zhou

View Form 483

Alcami Carolinas Corporation

Form 483 · February 6, 2026

Charleston, United States

Human Drugs

6

Observations

Issued by Brandy N Lepage, Victoria Spivak

View Form 483

Fenwal International, Inc.

Form 483 · February 5, 2026

Maricao, United States

Biologics

9

Observations

Issued by Scott T Ballard, Ramon L Gonzalez-Prieto

View Form 483

Excel Vision

Form 483 · January 22, 2026

Annonay, France

Human Drugs

13

Observations

Issued by Justin A Boyd, Khoa Nathan V Tran, Karen A Briggs

View Form 483

PPD Development Ireland Ltd.

Form 483 · December 19, 2025

Athlone, Ireland

Biologics

1

Observations

Issued by Peng Zhou, Thai D Truong

View Form 483

Simtra US LLC

Form 483 · December 11, 2025

Bloomington, United States

Biologics

2

Observations

Issued by Priscilla M Pastrana, Lizaida Perez

View Form 483

MD Wholesale Foods LLC

Form 483 · December 3, 2025

Hyattsville, United States

Foods & Cosmetics

10

Observations

Issued by Mohamad A Chahine, Karen A Spencer, Eric L Vangraafeiland, Kadija R Karimu

View Form 483

Chartwell Pharmaceuticals Congers, LLC

Form 483 · November 18, 2025

Congers, United States

Human Drugs

15

Observations

Issued by Lata C Mathew, Mindy M Chou, Syeda N Mahazabin

View Form 483

Grand River Aseptic Manufacturing Inc.

Form 483 · November 4, 2025

Caledonia, United States

Human Drugs

2

Observations

Issued by Jacob G Lutz

View Form 483

Catalent Greenville Inc

Form 483 · October 24, 2025

Greenville, United States

Human Drugs

3

Observations

Issued by Nicole E Knowlton, Santos E Camara

View Form 483

Zhejiang Jingxin Pharmaceutical Co., Ltd

Form 483 · October 17, 2025

Shaoxing, China

Human Drugs

2

Observations

Issued by Carolina D Vasquez

View Form 483

Bactolac Pharmaceutical, Inc.

Form 483 · September 24, 2025

Hauppauge, United States

Foods & Cosmetics

5

Observations

Issued by Meredith P Soehl

View Form 483

United Laboratories Manufacturing, LLC

Form 483 · August 15, 2025

Carrollton, United States

Human Drugs

8

Observations

Issued by Shelby N Turner, Mercedes N Overton

View Form 483

Surmasis Pharmaceutical, LLC

Form 483 · August 1, 2025

Des Moines, United States

Human Drugs

4

Observations

Issued by Katherine E Jacobitz, Cecilia H Kieu, Aranjeet Singh

View Form 483

Seaway Pharma Inc.

Form 483 · June 18, 2025

Massena, United States

Human Drugs

11

Observations

Issued by Edmund F Mrak, Ifechimere I Okafor

View Form 483

Pharmcore Inc. dba Hallandale Pharmacy

Form 483 · June 13, 2025

Fort Lauderdale, United States

Human Drugs

2

Observations

Issued by Logan T Williams

View Form 483

Lux Therapeutics LLC

Form 483 · June 6, 2025

Brookhaven, United States

Biologics

7

Observations

Issued by Mizanne E Lewis, Jannet M Peroti, Nerming V Briones

View Form 483

Octapharma Plasma Inc.

Form 483 · June 5, 2025

Sparks, United States

Biologics

2

Observations

Issued by Shelley H Beausoleil

View Form 483

Universal Packaging Systems, Inc.

Form 483 · May 29, 2025

Chino, United States

Human Drugs

6

Observations

Issued by Darren S Brown, Navneet Kaur, Ngozi G Offor

View Form 483

The Maros Group, LLC

Form 483 · May 28, 2025

Phoenix, United States

Foods & Cosmetics

8

Observations

Issued by Megan K Rand

View Form 483

Showing 24 of 45

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