Robert's Oxygen Company Inc. – FDA Inspection, Apr 10, 2019

Record Details

This FDA Inspection record concerns Robert's Oxygen Company Inc., with an inspection on April 10, 2019, issued by the Center for Drug Evaluation and Research, covering drugs.

Company: Robert's Oxygen Company Inc.
Inspection Date: April 10, 2019
Product Type: Drugs
Office: Center for Drug Evaluation and Research
Person: Laura D. Cain (Issuing Officer)

View Company Profile

ID · 517ebf0d-9ef1-46e5-af4b-5fbffcb26dfb

Inspection Facts

Voluntary Action Indicated (VAI)

Objectionable conditions were found, but FDA is not prepared to take or recommend regulatory action.

Inspection number: 1085813
FDA center: Human Drugs
Project area: Drug Quality Assurance
Outcome: Form 483 issued

FDA Citations

21 CFR 211.188(b)(8)Labeling control records including specimens or copies

Full citation text and observation details available on the Dashboard.

Discuss this record with AI

KeyPedia

ChatGPT

Claude

Perplexity

Grok

Copilot

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.

Explore Robert's Oxygen Company Inc.

FDA Inspection

Robert's Oxygen Company Inc.April 10, 2019