FDA Inspection
Rotech Healthcare Inc. dba Orion Home HealthRotech Healthcare Inc. dba Orion Home Health – FDA Inspection, Oct 12, 2011
Record Details
This FDA Inspection record concerns Rotech Healthcare Inc. dba Orion Home Health, with an inspection on October 12, 2011, issued by the Center for Drug Evaluation and Research, covering drugs.
- Inspection Date
- October 12, 2011
- Product Type
- Drugs
View Company Profile
ID · 374ac45c-aefe-4263-a729-d0249c8dccda
Inspection Facts
Voluntary Action Indicated (VAI)
Objectionable conditions were found, but FDA is not prepared to take or recommend regulatory action.
- Inspection number
- 749391
- FDA center
- Human Drugs
- Project area
- Drug Quality Assurance
FDA Citations
2- 21 CFR 211.67(c)Cleaning/maintenance records not kept
- 21 CFR 211.22(d)Procedures not in writing, fully followed
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.