FDA Inspection
Teligent Pharma, Inc.Teligent Pharma, Inc. – FDA Inspection, May 20, 2019
Record Details
This FDA Inspection record concerns Teligent Pharma, Inc., with an inspection on May 20, 2019, issued by the New Jersey District Office, covering human drugs.
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ID · 67eb4a19-49ae-4c3f-97a1-43cc71400846
Inspection Facts
- Inspection number
- 1090090
- FDA center
- Human Drugs
- Project area
- Drug Quality Assurance
- Outcome
- Form 483 issued
FDA Citations
10- 21 CFR 211.110(a)Control procedures to monitor and validate performance
- 21 CFR 211.165(f)Failing drug products not rejected
- 21 CFR 211.166(a)Written program not followed
- 21 CFR 211.180(c)Records not made readily available to FDA
- 21 CFR 211.180(e)(1)Review of representative number of batches
- 21 CFR 211.192Extent of discrepancy, failure investigations
- 21 CFR 211.192No written record of investigation
- 21 CFR 211.194(a)(6)Comparison of Test Results to Specifications
- 21 CFR 211.198(a)Procedures to be written and followed
- 21 CFR 314.81(b)(1)(ii)Contamination, chemical or physical change, deterioration
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Other FDA inspections of Teligent Pharma, Inc.
8| Date | Classification | Office | Project area |
|---|---|---|---|
| August 31, 2021 | OAI | Center for Drug Evaluation and Research | Drug Quality Assurance |
| October 19, 2017 | VAI | Center for Drug Evaluation and Research | Drug Quality Assurance |
| January 22, 2016 | NAI | Center for Drug Evaluation and Research | Bioresearch Monitoring |
| December 19, 2013 | NAI | Center for Drug Evaluation and Research | Drug Quality Assurance |
| February 2, 2012 | NAI | Center for Drug Evaluation and Research | Drug Quality Assurance |
Other documents for Teligent Pharma, Inc.
- FDA Inspection 1150271 - 2021-08-31
- FDA Inspection 1032023 - 2017-10-19
- FDA Inspection 956413 - 2016-01-22
- FDA Inspection 859472 - 2013-12-19
- FDA Inspection 765396 - 2012-02-02
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