FDA Inspection
Realm Labs, LLCRealm Labs, LLC – FDA Inspection, Jul 7, 2017
Record Details
This FDA Inspection record concerns Realm Labs, LLC, with an inspection on July 7, 2017, issued by the Center for Food Safety and Applied Nutrition, covering food/cosmetics.
View Company Profile
ID · 180ad697-83aa-4a4b-aae8-410a283587ad
Inspection Facts
Voluntary Action Indicated (VAI)
Objectionable conditions were found, but FDA is not prepared to take or recommend regulatory action.
- Inspection number
- 1017072
- FDA center
- Foods & Cosmetics
- Project area
- Food Composition, Standards, Labeling and Econ
- Outcome
- Form 483 issued
FDA Citations
5- 21 CFR 111.103Written procedures - quality control operations
- 21 CFR 111.70(e)Specifications - identity, purity, strength, composition
- 21 CFR 111.70(g)Specifications - finished packaging, labeling
- 21 CFR 111.475(b)(1)Written procedures - holding; distributing
- 21 CFR 111.570(b)(1)Written procedures - product complaint; review, investigate
Full citation text and observation details available on the Dashboard.
Other FDA inspections of Realm Labs, LLC
2| Date | Classification | Office | Project area |
|---|---|---|---|
| September 29, 2021 | NAI | Center for Food Safety and Applied Nutrition | Food Composition, Standards, Labeling and Econ |
| December 31, 2013 | VAI | Center for Drug Evaluation and Research | Unapproved and Misbranded Drugs |
Other documents for Realm Labs, LLC
- FDA Inspection 1153350 - 2021-09-29
- FDA Inspection 859010 - 2013-12-31
Document or profile
One record shows the event. A profile shows the pattern.
Buy this document for the source file and details behind this single event.
Choose full profile access to connect related records, sites, people, citations, and enforcement history in one view.