FDA Inspection
FillTech USA, LLCFillTech USA, LLC – FDA Inspection, Dec 19, 2025
Record Details
This FDA Inspection record concerns FillTech USA, LLC, with an inspection on December 19, 2025, issued by the Atlanta District Office, covering human drugs.
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ID · 9542e793-70a8-4e10-b3e3-4e1cda10bb0d
Inspection Facts
Voluntary Action Indicated (VAI)
Objectionable conditions were found, but FDA is not prepared to take or recommend regulatory action.
- Inspection number
- 1296652
- FDA center
- Human Drugs
- Project area
- Drug Quality Assurance
FDA Citations
6- 21 CFR 211.100(a)Absence of Written Procedures
- 21 CFR 211.142(b)Storage under appropriate conditions
- 21 CFR 211.180(e)Records reviewed annually
- 21 CFR 211.22(d)Procedures not in writing, fully followed
- 21 CFR 211.63Equipment Design, Size and Location
- 21 CFR 211.67(b)(4)Cleaning SOPs/equipment identification
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Other FDA inspections of FillTech USA, LLC
5| Date | Classification | Office | Project area |
|---|---|---|---|
| July 31, 2024 | NAI | Center for Food Safety and Applied Nutrition | Foodborne Biological Hazards |
| April 14, 2022 | VAI | Center for Drug Evaluation and Research | Drug Quality Assurance |
| September 29, 2016 | VAI | Center for Drug Evaluation and Research | Drug Quality Assurance |
| September 25, 2012 | NAI | Center for Drug Evaluation and Research | Drug Quality Assurance |
| February 24, 2010 | NAI | Center for Drug Evaluation and Research | Drug Quality Assurance |
Other documents for FillTech USA, LLC
- FDA Inspection 1244216 - 2024-07-31
- FDA Inspection 1167360 - 2022-04-14
- FDA Inspection 986761 - 2016-09-29
- FDA Inspection 801454 - 2012-09-25
- FDA Inspection 650545 - 2010-02-24
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