FDA Inspection
Txsyn Int. LLCTxsyn Int. LLC – FDA Inspection, Nov 14, 2023
Record Details
This FDA Inspection record concerns Txsyn Int. LLC, with an inspection on November 14, 2023, issued by the Center for Food Safety and Applied Nutrition, covering food/cosmetics.
- People
- Anthony L. Smith
- Jonaida Estevez Martinez (Issuing Officer)
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ID · 6c5cdd1b-4dfa-4198-b4ed-da5e501b0269
Inspection Facts
Official Action Indicated (OAI)
Significant objectionable conditions were found and regulatory or administrative action is recommended.
- Inspection number
- 1222431
- FDA center
- Foods & Cosmetics
- Project area
- Food Composition, Standards, Labeling and Econ
- Outcome
- Form 483 issued
- Enforcement
- Warning Letter
FDA Citations
17- 21 CFR 111.403Written procedures - labeling operations
- 21 CFR 111.403Written procedures -packaging operations
- 21 CFR 111.103Written procedure quality control operations material review
- 21 CFR 111.153Written procedures - product received; packaging, labeling
- 21 CFR 111.503Written procedures - returned dietary supplement
- 21 CFR 111.70(e)Specifications - identity, purity, strength, composition
- 21 CFR 111.475(b)(1)Written procedures - holding; distributing
- 21 CFR 111.465(b)Retain reserve samples - 1 year, 2 years
- 21 CFR 111.420(a)Repackaging, relabeling - quality control, approve
- 21 CFR 111.103Written procedure quality control operations material review
Showing 10 of 17 citations.
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Other FDA inspections of Txsyn Int. LLC
1| Date | Classification | Office | Project area |
|---|---|---|---|
| November 6, 2024 | Not classified | Dallas District Office | Food Composition, Standards, Labeling, and Economics |
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