Company
United StatesAcuLux, Inc., Naples, FL – FDA Inspections
Inspection records and compliance data for AcuLux, Inc. in Naples, Florida. 4 FDA inspections on record, 1 Form 483, last inspected August 08, 2019.
Company Profile
This profile covers AcuLux, Inc. based in Naples, Florida, United States.
FDA Inspection History
- FDA inspections
- 4
- OAI
- 0
- VAI
- 4
- NAI
- 0
- Form 483s
- 1
- Warning letters
- 0
First inspected February 25, 2009. Last inspected August 8, 2019.
Most cited issue areas
- Lack of or inadequate complaint procedures2 inspections
- Lack of or inadequate procedures2 inspections
- Lack of Written MDR Procedures2 inspections
FDA inspections (4)
| Date | Result | FDA center(s) | Insp. # |
|---|---|---|---|
| August 8, 2019 | VAI | Medical Devices & Rad Health · Compliance: Devices | 1099382 |
| September 4, 2015 | VAI | Medical Devices & Rad Health · Compliance: Devices | 940918 |
| May 30, 2012 | VAI | Medical Devices & Rad Health · Compliance: Devices | 783891 |
| February 25, 2009 | VAI | Medical Devices & Rad Health · Postmarket Assurance: Devices | 598305 |
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
AcuLux, Inc.
FEI Number
3002907759
Address
2277 Trade Center Way Ste 102, Naples, Florida 34109, United States
Country
United States
ID: 1f996d0f-92a6-4e95-ba7f-4f2cc71ce6ec