FDA Inspection
Ocular Systems, Inc.Ocular Systems, Inc. – FDA Inspection, Sep 9, 2009
Record Details
This FDA Inspection record concerns Ocular Systems, Inc., with an inspection on September 9, 2009, issued by the Center for Biologics Evaluation and Research, covering biologics.
- Company
- Ocular Systems, Inc.
- Inspection Date
- September 9, 2009
- Product Type
- Biologics
View Company Profile
ID · 65aed59a-471a-4607-8454-46582f5b8a53
Inspection Facts
Voluntary Action Indicated (VAI)
Objectionable conditions were found, but FDA is not prepared to take or recommend regulatory action.
- Inspection number
- 611822
- FDA center
- Biologics
- Project area
- Human Cellular, Tissue, and Gene Therapies
FDA Citations
23- 21 CFR 1271.55(a)(3)Summary--records used to make determination
- 21 CFR 1271.195(c)Monitoring--cross contamination, exposure to CD
- 21 CFR 1271.195(a)Adequate control, proper conditions
- 21 CFR 1271.195(a)(3)Aseptic processing---cleaning, disinfecting
- 21 CFR 1271.200(a)Design appropriate, suitably located
- 21 CFR 1271.350(b)(2)Deviations not reported to FDA
- 21 CFR 1271.220(a)Causing contamination, increasing risks
- 21 CFR 1271.265(a)Acceptance criteria designed to prevent CD
- 21 CFR 1271.250(c)All labeling requirements met
- 21 CFR 1271.190(c)Separate or defined operational areas
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Other FDA inspections of Ocular Systems, Inc.
1| Date | Classification | Office | Project area |
|---|---|---|---|
| September 29, 2010 | VAI | Center for Biologics Evaluation and Research | Human Cellular, Tissue, and Gene Therapies |
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