FDA Inspection
Marco Pharma International, LLCMarco Pharma International, LLC – FDA Inspection, May 22, 2019
Record Details
This FDA Inspection record concerns Marco Pharma International, LLC, with an inspection on May 22, 2019, issued by the Center for Food Safety and Applied Nutrition, covering food/cosmetics.
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ID · 7f221bbf-6286-4043-9a2a-0de5a4811c94
Inspection Facts
Official Action Indicated (OAI)
Significant objectionable conditions were found and regulatory or administrative action is recommended.
- Inspection number
- 1091383
- FDA center
- Foods & Cosmetics
- Project area
- Food Composition, Standards, Labeling and Econ
- Outcome
- Form 483 issued
FDA Citations
8- 21 CFR 111.70(c)(1)In-process identity, purity, strength, composition
- 21 CFR 111.70(g)Specifications - finished packaging, labeling
- 21 CFR 111.103Written procedures - quality control operations
- 21 CFR 117.4Training of employees and records
- 21 CFR 111.55Production, process controls - implement
- 21 CFR 111.35(b)(4)Records - equipment; calibrations, inspections, checks
- 21 CFR 111.415(b)Dietary supplement - protect, contamination
- 21 CFR 111.210(g)Packaging description, representative label
Full citation text and observation details available on the Dashboard.
Other FDA inspections of Marco Pharma International, LLC
3| Date | Classification | Office | Project area |
|---|---|---|---|
| January 23, 2024 | NAI | Center for Food Safety and Applied Nutrition | Food Composition, Standards, Labeling and Econ |
| September 3, 2020 | VAI | Center for Food Safety and Applied Nutrition | Food Composition, Standards, Labeling and Econ |
| June 17, 2016 | VAI | Center for Food Safety and Applied Nutrition | Foodborne Biological Hazards |
Other documents for Marco Pharma International, LLC
- FDA Inspection 1232461 - 2024-01-23
- FDA Inspection 1128732 - 2020-09-03
- FDA Inspection 979389 - 2016-06-17
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