FDA Inspection
Ocular Systems, Inc.Ocular Systems, Inc. – FDA Inspection, Sep 29, 2010
Record Details
This FDA Inspection record concerns Ocular Systems, Inc., with an inspection on September 29, 2010, issued by the Center for Biologics Evaluation and Research, covering biologics.
- Company
- Ocular Systems, Inc.
- Inspection Date
- September 29, 2010
- Product Type
- Biologics
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ID · fcf1a3e4-2b2d-44a3-bbb4-dce4d3aa47aa
Inspection Facts
Voluntary Action Indicated (VAI)
Objectionable conditions were found, but FDA is not prepared to take or recommend regulatory action.
- Inspection number
- 683197
- FDA center
- Biologics
- Project area
- Human Cellular, Tissue, and Gene Therapies
FDA Citations
10- 21 CFR 1271.265(d)Shipping conditions appropriate
- 21 CFR 1271.195(a)Adequate control, proper conditions
- 21 CFR 1271.195(a)(3)Aseptic processing---cleaning, disinfecting
- 21 CFR 1271.170(b)Qualifications lacking
- 21 CFR 1271.265(e)Procedures and release criteria
- 21 CFR 1271.225Verification/validation
- 21 CFR 1271.230(a)Validation & approval--established procedures
- 21 CFR 1271.160(d)Validation for intended use
- 21 CFR 1271.160(b)(5)Monitoring systems
- 21 CFR 1271.55(b)(3)Name and address on summary
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Other FDA inspections of Ocular Systems, Inc.
1| Date | Classification | Office | Project area |
|---|---|---|---|
| September 9, 2009 | VAI | Center for Biologics Evaluation and Research | Human Cellular, Tissue, and Gene Therapies |
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