Teligent, Inc.
FDA inspection history in Buena, New Jersey, 2011 to 2021
- 4
- Form 483s
- 1
- Close-out
- 1
- EIR
Every document, by year
- Form 483
- Close-out
- EIR
2011: one Form 483; 2016: one inspection report; 2017: one Form 483; 2019: one close-out letter and one Form 483; 2021: one Form 483.
The story so far
Built from the dates and citations on the documents themselves.
- 2011One Form 483, at Buena, New Jersey.
- 2016–21Three Form 483s, one inspection report and one close-out letter, at Buena, New Jersey.
- 2021The longest 483 on file: 15 observations over 24 pages at Buena, New Jersey.
Cited most
Across all Teligent observations on file
- 21 CFR 211.192Production record review5
- 21 CFR 211.25(a)Personnel qualifications4
- 21 CFR 211.160General requirements3
- 21 CFR 211.165Testing and release for distribution3
- 21 CFR 211.110Sampling and testing of in-process materials and drug products2
The complete Teligent file.
All 6 documents as original PDFs, in one order. For supplier audits, diligence and inspection prep.
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Sites
Buena, New Jersey
Four Form 483s, one close-out letter and one inspection report · 2011 to 2021 · 32 observations
Latest: Form 483, Aug 31, 2021 →
Documents
6 on file, newest first| Date | Document | Location | Observations | Price |
|---|---|---|---|---|
| 2021-08-31 | 483 Form 483 | Buena, New Jersey | 15 | $99 |
| 2019-11-26 | Close-out Close-out letter | Buena, New Jersey | — | $99 |
| 2019-05-20 | 483 Form 483 | Buena, New Jersey | 10 | $99 |
| 2017-10-19 | 483 Form 483 | Buena, New Jersey | 6 | $99 |
| 2016-09-16 | EIR EIR | Buena, New Jersey | — | $550 |
| 2011-03-08 | 483 Form 483 | Buena, New Jersey | 1 | $99 |
Investigators on these documents
Nancy M. Espinal (3)Himanshu Gupta (1)Kristina L. Conroy (1)Paul L. Bellamy (1)Rachael O. Oyewole (1)
FEI number 1000526875 · most recent document Aug 31, 2021
About Teligent, Inc.
How many FDA Form 483s has Teligent, Inc. received?
FDA Intel has 4 Form 483s on file for Teligent, Inc.; the most recent is dated Aug 31, 2021.
When was Teligent, Inc. last inspected by FDA?
The most recent FDA inspection document on file for Teligent, Inc. is a Form 483 dated Aug 31, 2021, for the site in Buena, New Jersey.
What did FDA cite at Teligent, Inc.?
The regulations cited most in the observations on file for Teligent, Inc. are 21 CFR 211.192 (Production record review), 5 times; 21 CFR 211.25(a) (Personnel qualifications), 4 times; 21 CFR 211.160 (General requirements), 3 times.