Company
United StatesLightwave International, LLC, Bridgeville, PA – FDA Inspections
Inspection records and compliance data for Lightwave International, LLC in Bridgeville, Pennsylvania. 5 FDA inspections on record, 1 Form 483, last inspected September 04, 2018.
Company Profile
This profile covers Lightwave International, LLC based in Bridgeville, Pennsylvania, United States.
FDA Inspection History
- FDA inspections
- 5
- OAI
- 0
- VAI
- 2
- NAI
- 2
- Unclassified
- 1
- Form 483s
- 1
- Warning letters
- 0
First inspected October 15, 2008. Last inspected September 4, 2018.
Most cited issue areas
- Class IV "Danger" label1 inspection
- Controls, maintenance1 inspection
- ID label lacks name and address1 inspection
FDA inspections (5)
| Date | Result | FDA center(s) | Insp. # |
|---|---|---|---|
| September 4, 2018 | Not classified | Medical Devices & Rad Health · Radiation Control and Health Safety Act | 1064504 |
| March 22, 2013 | VAI | Medical Devices & Rad Health · Radiation Control and Health Safety Act | 825692 |
| March 23, 2012 | VAI | Medical Devices & Rad Health · Radiation Control and Health Safety Act | 773878 |
| April 26, 2011 | NAI | Medical Devices & Rad Health · Radiation Control and Health Safety Act | 722619 |
| October 15, 2008 | NAI | Medical Devices & Rad Health · Radiation Control and Health Safety Act | 621508 |
FDA documents
No Form 483s, Warning Letters or EIRs on record.
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Companies with similar regulatory profiles, compliance history, and operations.
Company Information
Name
Lightwave International, LLC
FEI Number
3006800222
Address
500 Old Pond Rd, Bridgeville, Pennsylvania 15017, United States
Country
United States
ID: 5cb73217-80e6-443e-9254-959e14a44e42