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•United States

FillTech USA, LLC, Rockwell, NC – FDA Inspections

Inspection records and compliance data for FillTech USA, LLC in Rockwell, North Carolina. 6 FDA inspections on record, 1 Form 483, last inspected December 19, 2025.

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Company Profile

This profile covers FillTech USA, LLC based in Rockwell, North Carolina, United States.

FDA Inspection History

FDA inspections
6
OAI
0
VAI
3
NAI
3
Form 483s
1
Warning letters
0

First inspected February 24, 2010. Last inspected December 19, 2025.

Most cited issue areas

  • Equipment Design, Size and Location2 inspections
  • Storage under appropriate conditions2 inspections
  • Absence of Written Procedures1 inspection

FDA inspections (6)

DateResultFDA center(s)Insp. #
December 19, 2025VAIHuman Drugs · Drug Quality Assurance1296652
July 31, 2024NAIFoods & Cosmetics · Foodborne Biological Hazards1244216
April 14, 2022VAIHuman Drugs · Drug Quality Assurance1167360
September 29, 2016VAIHuman Drugs · Drug Quality Assurance986761
September 25, 2012NAIHuman Drugs · Drug Quality Assurance801454
February 24, 2010NAIFoods & Cosmetics, Human Drugs · Drug Quality Assurance650545
FDA documents

Form 483s (2)

  • Form 483s · December 19, 2025
  • Form 483s · April 14, 2022
People (3)
Angelica M. Hernandez
Person
Harshal J. Desai
Person
Mercedes N. Overton
Person
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NuCare Pharmaceuticals Inc
HF Acquisition Co LLC
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Company Information

Name

FillTech USA, LLC

FEI Number

1000512200

Address

380 Palmer Rd, Rockwell, North Carolina 28138, United States

Country

United States

ID: dfe3278f-cccc-47fa-813c-d3b3fdee2da2

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