FDA Inspection
UnityPoint at HomeUnityPoint at Home – FDA Inspection, May 16, 2013
Record Details
This FDA Inspection record concerns UnityPoint at Home, with an inspection on May 16, 2013, issued by the Center for Drug Evaluation and Research, covering drugs.
- Company
- UnityPoint at Home
- Inspection Date
- May 16, 2013
- Product Type
- Drugs
View Company Profile
ID · 31abf290-bb95-4612-acea-b61b7fea642e
Inspection Facts
Voluntary Action Indicated (VAI)
Objectionable conditions were found, but FDA is not prepared to take or recommend regulatory action.
- Inspection number
- 832451
- FDA center
- Human Drugs
- Project area
- Drug Quality Assurance
FDA Citations
4- 21 CFR 211.105(b)Distinctive ID or code not recorded in batch record
- 21 CFR 211.160(b)(4)Calibration - at intervals, written program, remedial action
- 21 CFR 211.100(a)Approval and review of procedures
- 21 CFR 211.122(a)Written procedures not 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.