FDA Inspection
Teligent Pharma, Inc.Teligent Pharma, Inc. – FDA Inspection, Aug 31, 2021
Record Details
This FDA Inspection record concerns Teligent Pharma, Inc., with an inspection on August 31, 2021, issued by the Center for Drug Evaluation and Research, covering drugs.
- Company
- Teligent Pharma, Inc.
- Inspection Date
- August 31, 2021
- Product Type
- Drugs
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ID · eb729f01-1b0b-4787-bbb2-2ec0cd04754f
Inspection Facts
Official Action Indicated (OAI)
Significant objectionable conditions were found and regulatory or administrative action is recommended.
- Inspection number
- 1150271
- FDA center
- Human Drugs
- Project area
- Drug Quality Assurance
FDA Citations
15- 21 CFR 314.81(b)(1)(ii)Failure to meet specifications
- 21 CFR 211.188(b)(1)Dates not included for each significant step
- 21 CFR 211.110(a)Control procedures to monitor and validate performance
- 21 CFR 211.137(a)Expiration date lacking
- 21 CFR 211.25(a)Training , Education , Experience overall
- 21 CFR 211.67(a)Cleaning / Sanitizing / Maintenance
- 21 CFR 211.160(a)Following/documenting laboratory controls
- 21 CFR 211.25(a)GMP Training Frequency
- 21 CFR 211.192Extent of discrepancy, failure investigations
- 21 CFR 211.194(a)(8)Second person sign off
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Other FDA inspections of Teligent Pharma, Inc.
8| Date | Classification | Office | Project area |
|---|---|---|---|
| May 20, 2019 | Not classified | New Jersey District Office | 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 1090090 - 2019-05-20
- 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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