Company
United StatesLeading Pharma, LLC, Fairfield, NJ – FDA Inspections
Inspection records and compliance data for Leading Pharma, LLC in Fairfield, New Jersey. 11 FDA inspections on record, 3 Form 483s, last inspected October 21, 2024.
Company Profile
This profile covers Leading Pharma, LLC based in Fairfield, New Jersey, United States.
FDA Inspection History
- FDA inspections
- 11
- OAI
- 0
- VAI
- 9
- NAI
- 2
- Form 483s
- 3
- Warning letters
- 0
First inspected October 8, 2009. Last inspected October 21, 2024.
Most cited issue areas
- Absence of Written Procedures1 inspection
- Computer control of master formula records1 inspection
- Failure to meet specifications1 inspection
FDA inspections (11)
| Date | Result | FDA center(s) | Insp. # |
|---|---|---|---|
| October 21, 2024 | VAI | Human Drugs · Drug Quality Assurance | 1251315 |
| August 11, 2020 | NAI | Human Drugs · Bioresearch Monitoring | 1129205 |
| January 31, 2019 | VAI | Human Drugs · Drug Quality Assurance | 1079111 |
| August 31, 2018 | NAI | Human Drugs · Drug Quality Assurance | 1067964 |
| April 14, 2017 | VAI | Human Drugs · Postmarket Surv. and Epidemiology | 1010916 |
| March 10, 2016 | VAI | Human Drugs · Drug Quality Assurance | 965261 |
| March 6, 2015 | VAI | Human Drugs · Bioresearch Monitoring | 917200 |
| June 12, 2013 | VAI | Human Drugs · Postmarket Surv. and Epidemiology | 836069 |
| January 23, 2012 | VAI | Human Drugs · Drug Quality Assurance | 761489 |
| January 6, 2011 | VAI | Human Drugs · Drug Quality Assurance | 702887 |
| October 8, 2009 | VAI | Human Drugs · Drug Quality Assurance | 619131 |
FDA documents
Form 483s (1)
EIRs (1)
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Company Information
Name
Leading Pharma, LLC
FEI Number
3001611969
Address
3 Oak Rd, Fairfield, New Jersey 07004, United States
Country
United States
ID: 9cbe169a-2e1b-4cdb-848c-209798a79db0