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•United States

Alcami Carolinas Corporation, Wilmington, NC – FDA Inspections

Inspection records and compliance data for Alcami Carolinas Corporation in Wilmington, North Carolina. 14 FDA inspections on record, 2 Form 483s, last inspected September 26, 2025.

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Company Profile

This profile covers Alcami Carolinas Corporation based in Wilmington, North Carolina, United States.

FDA Inspection History

FDA inspections
14
OAI
0
VAI
3
NAI
11
Form 483s
2
Warning letters
0

First inspected December 4, 2009. Last inspected September 26, 2025.

Most cited issue areas

  • Cleaning / Sanitizing / Maintenance1 inspection
  • Procedures for non-sterile drug products1 inspection
  • SOPs not followed / documented1 inspection

FDA inspections (14)

DateResultFDA center(s)Insp. #
September 26, 2025NAIAnimal Drugs & Feeds, Human Drugs · Monitoring of Marketed Animal Drugs, Feeds, and Devices1285106
January 31, 2025VAIBiologics · Human Cellular, Tissue, and Gene Therapies1259644
February 18, 2021NAIHuman Drugs · Drug Quality Assurance1137604
August 9, 2019NAIAnimal Drugs & Feeds · Monitoring of Marketed Animal Drugs, Feed, and Devices1101779
March 7, 2019NAIHuman Drugs · Bioresearch Monitoring1084710
January 29, 2019NAIHuman Drugs · Drug Quality Assurance1080667
August 1, 2017NAIFoods & Cosmetics · Food Composition, Standards, Labeling and Econ1022149
February 10, 2017NAIAnimal Drugs & Feeds, Human Drugs · Drug Quality Assurance1011649
August 19, 2016NAIHuman Drugs · Drug Quality Assurance988283
July 16, 2014NAIHuman Drugs · Drug Quality Assurance887474
May 3, 2013NAIHuman Drugs · Drug Quality Assurance835713
March 27, 2012VAIHuman Drugs · Drug Quality Assurance775633
August 26, 2010VAIHuman Drugs · Drug Quality Assurance684022
December 4, 2009NAIHuman Drugs · Drug Quality Assurance636145
FDA documents

Form 483s (2)

  • Form 483s · September 26, 2025
  • Form 483s · January 31, 2025

EIRs (4)

  • EIRs · September 26, 2025
  • EIRs · February 18, 2021
  • EIRs · August 9, 2019
  • EIRs · January 29, 2019
Other regulators (1)
  • UK MHRA · 6 inspections · last November 14, 2016
People (6)
Mark Lewis
Person
Scott Jedrey
Person
Gwendalynn Ritchie
Person
Joseph Payne
Person
Kenneth A. Domagalski
Person
Jacquelyn Uribe
Person
Related Companies (10)

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Consumer Product Partners, LLC
Newton Laboratories, Inc.
Roberts Oxygen Company Inc
GF Health Products, Inc.
Company Information

Name

Alcami Carolinas Corporation

FEI Number

1049418

Address

2320 Scientific Park Dr, Wilmington, North Carolina 28405, United States

Country

United States

ID: c58574ae-b205-4ac2-ae4c-ef29281b0110

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