FDA Inspection
Option CareOption Care – FDA Inspection, Nov 25, 2014
Record Details
This FDA Inspection record concerns Option Care, with an inspection on November 25, 2014, issued by the Center for Drug Evaluation and Research, covering drugs.
- Company
- Option Care
- Inspection Date
- November 25, 2014
- Product Type
- Drugs
View Company Profile
ID · badbe871-6964-455d-8fcf-4d785ab4ee8c
Inspection Facts
Official Action Indicated (OAI)
Significant objectionable conditions were found and regulatory or administrative action is recommended.
- Inspection number
- 905659
- FDA center
- Human Drugs
- Project area
- Drug Quality Assurance
FDA Citations
7- 21 CFR 211.46(c)Exhaust systems inadequate to control air contamination
- 21 CFR 211.160(a)Following/documenting laboratory controls
- 21 CFR 211.113(b)Procedures for sterile drug products
- 21 CFR 211.28(b)Habits of good sanitation & health
- 21 CFR 211.28(a)Protective Apparel Not Worn
- 21 CFR 211.166(a)Lack of written stability program
- 21 CFR 211.56(b)Written sanitation procedures not followed
Full citation text and observation details available on the Dashboard.
Other FDA inspections of Option Care
1| Date | Classification | Office | Project area |
|---|---|---|---|
| August 2, 2017 | Not classified | Dallas District Office |
Other documents for Option Care
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.