Company
United StatesNavinta, LLC, Ewing, NJ – FDA Inspections
Inspection records and compliance data for Navinta, LLC in Ewing, New Jersey. 8 FDA inspections on record (1 OAI), 4 Form 483s, last inspected September 30, 2024.
Company Profile
This profile covers Navinta, LLC based in Ewing, New Jersey, United States.
FDA Inspection History
- FDA inspections
- 8
- OAI
- 1
- VAI
- 2
- NAI
- 2
- Unclassified
- 3
- Form 483s
- 4
- Warning letters
- 0
First inspected August 10, 2015. Last inspected September 30, 2024.
Most cited issue areas
- Design control - no procedures1 inspection
- Evaluation of suppliers, contractors, etc., requirements1 inspection
- Failure to develop written procedures1 inspection
FDA inspections (8)
| Date | Result | FDA center(s) | Insp. # |
|---|---|---|---|
| September 30, 2024 | Not classified | Human Drugs | 1252822 |
| June 29, 2023 | Not classified | Human Drugs | 1209856 |
| May 4, 2023 | NAI | Human Drugs · Bioresearch Monitoring | 1205480 |
| March 28, 2019 | VAI | Human Drugs · Bioresearch Monitoring | 1084188 |
| September 18, 2018 | Not classified | Human Drugs | 1070302 |
| August 18, 2017 | VAI | Human Drugs · Postmarket Surv. and Epidemiology | 1022105 |
| May 16, 2016 | OAI | Human Drugs · Bioresearch Monitoring | 971010 |
| August 10, 2015 | NAI | Human Drugs · Drug Quality Assurance | 937748 |
FDA documents
Form 483s (2)
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Company Information
Name
Navinta, LLC
FEI Number
3004375014
Address
1499 Lower Ferry Rd, Ewing, New Jersey 08618, United States
Country
United States
ID: 2049d986-174a-414f-812b-0f4347426e48