FDA Inspection
Lightwave International, LLCLightwave International, LLC – FDA Inspection, Sep 4, 2018
Record Details
This FDA Inspection record concerns Lightwave International, LLC, with an inspection on September 4, 2018, issued by the Philadelphia District Office, covering medical devices & rad health.
- Company
- Lightwave International, LLC
- Inspection Date
- September 4, 2018
- Product Type
- Medical Devices & Rad Health
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ID · 8db0d536-1705-4e24-b36f-4cd62e202a44
Inspection Facts
- Inspection number
- 1064504
- FDA center
- Medical Devices & Rad Health
- Project area
- Radiation Control and Health Safety Act
- Outcome
- Form 483 issued
FDA Citations
6- 21 CFR 1002.30(a)(1)Quality control procedures
- 21 CFR 1010.3(a)(1)ID label lacks name and address
- 21 CFR 1010.3(a)(2)ID label lacks place, month & year of manufacture
- 21 CFR 1010.4(d)Variances - Improper certification
- 21 CFR 1040.10(g)(3)Class IV "Danger" label
- 21 CFR 1040.10(h)(2)(ii)Controls, maintenance
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Other FDA inspections of Lightwave International, LLC
4| Date | Classification | Office | Project area |
|---|---|---|---|
| March 22, 2013 | VAI | Center for Devices and Radiological Health | Radiation Control and Health Safety Act |
| March 23, 2012 | VAI | Center for Devices and Radiological Health | Radiation Control and Health Safety Act |
| April 26, 2011 | NAI | Center for Devices and Radiological Health | Radiation Control and Health Safety Act |
| October 15, 2008 | NAI | Center for Devices and Radiological Health | Radiation Control and Health Safety Act |
Other documents for Lightwave International, LLC
- FDA Inspection 825692 - 2013-03-22
- FDA Inspection 773878 - 2012-03-23
- FDA Inspection 722619 - 2011-04-26
- FDA Inspection 621508 - 2008-10-15
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