FDA Inspection
Oxarc, LLCOxarc, LLC – FDA Inspection, Jul 14, 2017
Record Details
This FDA Inspection record concerns Oxarc, LLC, with an inspection on July 14, 2017, issued by the Center for Drug Evaluation and Research, covering drugs.
View Company Profile
ID · 2848ec19-a366-4e01-8aa7-0f25407e3e25
Inspection Facts
Voluntary Action Indicated (VAI)
Objectionable conditions were found, but FDA is not prepared to take or recommend regulatory action.
- Inspection number
- 1018413
- FDA center
- Human Drugs
- Project area
- Drug Quality Assurance
- Outcome
- Form 483 issued
FDA Citations
3- 21 CFR 211.25(a)GMP Training Frequency
- 21 CFR 211.142Written warehousing procedures established/followed
- 21 CFR 211.67(c)Cleaning/maintenance records not kept
Full citation text and observation details available on the Dashboard.
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.