FDA Inspection
LasikPlusLasikPlus – FDA Inspection, Jul 14, 2009
Record Details
This FDA Inspection record concerns LasikPlus, with an inspection on July 14, 2009, issued by the Center for Devices and Radiological Health, covering devices.
- Company
- LasikPlus
- Inspection Date
- July 14, 2009
- Product Type
- Devices
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ID · 0b88c241-94a2-4501-8947-3f619290e76a
Inspection Facts
Official Action Indicated (OAI)
Significant objectionable conditions were found and regulatory or administrative action is recommended.
- Inspection number
- 596008
- FDA center
- Medical Devices & Rad Health
- Project area
- Compliance: Devices
FDA Citations
4- 21 CFR 803.33(a)Failure to Submit Annual Reports
- 21 CFR 803.18(b)(1)(i)Adverse events--all info not in file
- 21 CFR 803.30(a)(2)Report of Serious Injury Within 10 Days
- 21 CFR 803.17(a)(1)Lack of System for Event Evaluations
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