FDA Inspection 1085813 — Robert's Oxygen Company Inc.

Robert's Oxygen Company Inc. — FEI 3007349281

The FDA completed an inspection of Robert's Oxygen Company Inc. on April 10, 2019 in Charlotte, NC. The inspection was classified VAI (Voluntary Action Indicated — objectionable conditions were found but do not meet the threshold for regulatory action). 1 citation was issued during this inspection. Product area: Drugs.

Inspection Details

Classification
Voluntary Action Indicated (VAI) (VAI)
End Date
April 10, 2019
Fiscal Year
2019
Product Type
Drugs
Project Area
Drug Quality Assurance
Location
Charlotte, NC (United States)

Citations

IDCFRDescription
437221 CFR 211.188(b)(8)Labeling control records including specimens or copies