FDA Inspection
Ocusoft Inc.Ocusoft Inc. – FDA Inspection, Oct 17, 2018
Record Details
This FDA Inspection record concerns Ocusoft Inc., with an inspection on October 17, 2018, issued by the Center for Drug Evaluation and Research, covering drugs.
View Company Profile
ID · 613507d2-efa0-41e6-8ff1-7e8a2a7790b6
Inspection Facts
Voluntary Action Indicated (VAI)
Objectionable conditions were found, but FDA is not prepared to take or recommend regulatory action.
- Inspection number
- 1069053
- FDA center
- Human Drugs
- Project area
- Drug Quality Assurance
- Outcome
- Form 483 issued
FDA Citations
2- 21 CFR 211.68(b)Written record not kept of program and validation data
- 21 CFR 211.100(a)Changes to Procedures Not Reviewed, Approved
Full citation text and observation details available on the Dashboard.
Other FDA inspections of Ocusoft Inc.
2| Date | Classification | Office | Project area |
|---|---|---|---|
| December 14, 2016 | NAI | Center for Drug Evaluation and Research | Drug Quality Assurance |
| March 28, 2013 | NAI | Center for Devices and Radiological Health | Compliance: Devices |
Other documents for Ocusoft Inc.
- FDA Inspection 995258 - 2016-12-14
- FDA Inspection 824806 - 2013-03-28
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.