Company
United StatesTeligent Pharma, Inc., Buena, NJ – FDA Inspections
Inspection records and compliance data for Teligent Pharma, Inc. in Buena, New Jersey. 9 FDA inspections on record (1 OAI), 2 Form 483s, 1 warning letter, last inspected August 31, 2021.
Company Profile
This profile covers Teligent Pharma, Inc. based in Buena, New Jersey, United States.
FDA Inspection History
- FDA inspections
- 9
- OAI
- 1
- VAI
- 2
- NAI
- 5
- Unclassified
- 1
- Form 483s
- 2
- Warning letters
- 1
First inspected June 24, 2009. Last inspected August 31, 2021.
Most cited issue areas
- Control procedures to monitor and validate performance2 inspections
- Extent of discrepancy, failure investigations2 inspections
- No written record of investigation2 inspections
FDA inspections (9)
| Date | Result | FDA center(s) | Insp. # |
|---|---|---|---|
| August 31, 2021 | OAI | Human Drugs · Drug Quality Assurance | 1150271 |
| May 20, 2019 | Not classified | Human Drugs · Drug Quality Assurance | 1090090 |
| October 19, 2017 | VAI | Human Drugs · Drug Quality Assurance | 1032023 |
| January 22, 2016 | NAI | Human Drugs · Bioresearch Monitoring | 956413 |
| December 19, 2013 | NAI | Human Drugs · Drug Quality Assurance | 859472 |
| February 2, 2012 | NAI | Foods & Cosmetics, Human Drugs · Drug Quality Assurance | 765396 |
| March 8, 2011 | VAI | Human Drugs · Drug Quality Assurance | 712964 |
| July 28, 2009 | NAI | Animal Drugs & Feeds · Monitoring of Marketed Animal Drugs, Feed, and Devices | 599782 |
| June 24, 2009 | NAI | Human Drugs · Drug Quality Assurance | 592263 |
FDA documents
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Company Information
Name
Teligent Pharma, Inc.
FEI Number
1000526875
Address
105 Lincoln Avenue, Buena, New Jersey 08310, United States
Country
United States
ID: 1605ff29-0e1f-49ed-9bba-a5f897375249