Company
United StatesAustarPharma, LLC - Inspection Records
Inspection records and compliance data for AustarPharma, LLC in Edison, New Jersey. 7 FDA inspections on record, 2 Form 483s, last inspected December 04, 2024.
Company Profile
This profile covers AustarPharma, LLC based in Edison, New Jersey, United States.
FDA Inspection History
- FDA inspections
- 7
- OAI
- 0
- VAI
- 6
- NAI
- 1
- Form 483s
- 2
- Warning letters
- 0
First inspected June 3, 2011. Last inspected December 4, 2024.
Most cited issue areas
- Cleaning / Sanitizing / Maintenance1 inspection
- Establishment of calibration procedures1 inspection
- Failure to develop written procedures1 inspection
Most recent inspections
| Date | Classification | Office | Project area |
|---|---|---|---|
| December 4, 2024 | VAI | New Jersey District Office | Postmarketing Surveillance and Epidemiology: Human Drugs |
| April 5, 2023 | VAI | Center for Drug Evaluation and Research | Drug Quality Assurance |
| January 5, 2018 | VAI | Center for Drug Evaluation and Research | Drug Quality Assurance |
| May 25, 2016 | VAI | Center for Drug Evaluation and Research | Drug Quality Assurance |
| December 18, 2013 | VAI | Center for Drug Evaluation and Research | Drug Quality Assurance |
Documents (9)
FDA Inspection 1236866 - AustarPharma, LLC - 2024-12-04
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FDA Inspection 1236866 - AustarPharma, LLC - 2024-12-04
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483 - AustarPharma, LLC - 2023-04-05
483
FDA Inspection 1201798 - AustarPharma, LLC - 2023-04-05
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FDA Inspection 1037881 - AustarPharma, LLC - 2018-01-05
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FDA Inspection 973353 - AustarPharma, LLC - 2016-05-25
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FDA Inspection 858222 - AustarPharma, LLC - 2013-12-18
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FDA Inspection 785076 - AustarPharma, LLC - 2012-06-05
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FDA Inspection 728323 - AustarPharma, LLC - 2011-06-03
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Search nearby companiesCompany Information
Name
AustarPharma, LLC
FEI Number
3008953516
State
New Jersey
City
Edison
ID: 05a402ea-dcb1-4900-9553-0a3a1b908183