FDA Inspection
RXW CGMP, LLCRXW CGMP, LLC – FDA Inspection, Jul 21, 2017
Record Details
This FDA Inspection record concerns RXW CGMP, LLC, with an inspection on July 21, 2017, issued by the Center for Food Safety and Applied Nutrition, covering food/cosmetics.
- People
- Jacob A. Clark (Issuing Officer)
- Kathryn A. Cutajar (Issuing Officer)
- Martin R. Vowell (Investigator)
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ID · ee6473e6-568b-4325-8368-e9b4df7c11a8
Inspection Facts
Official Action Indicated (OAI)
Significant objectionable conditions were found and regulatory or administrative action is recommended.
- Inspection number
- 1018703
- FDA center
- Foods & Cosmetics
- Project area
- Food Composition, Standards, Labeling and Econ
- Outcome
- Form 483 issued
FDA Citations
19- 21 CFR 111.75(a)(2)(ii)(B)Component - certificate of analysis
- 21 CFR 111.210(h)(3)(ii)(B)Components; add, verify
- 21 CFR 111.210(h)(5)Corrective action plans
- 21 CFR 111.70(b)(1)Specifications - component identity
- 21 CFR 111.70(d)Specifications - labels, packaging
- 21 CFR 111.70(e)Specifications - contamination limits
- 21 CFR 111.70(e)Specifications - identity, purity, strength, composition
- 21 CFR 111.35(b)(3)Documentation - instruments, controls; calibrations
- 21 CFR 111.180(b)(3)Documentation - components
- 21 CFR 111.180(b)(2)Records - receiving; components, packaging, labels, products
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Other FDA inspections of RXW CGMP, LLC
2| Date | Classification | Office | Project area |
|---|---|---|---|
| June 28, 2011 | VAI | Center for Food Safety and Applied Nutrition | Food Composition, Standards, Labeling and Econ |
| July 2, 2009 | NAI | Center for Food Safety and Applied Nutrition | Foodborne Biological Hazards |
Other documents for RXW CGMP, LLC
- FDA Inspection 729754 - 2011-06-28
- FDA Inspection 594698 - 2009-07-02
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