Teligent, Inc.
Form 483 issued August 31, 2021 · Buena, New Jersey
- Inspection
- Jul 12 – Aug 31, 2021
- Investigators
- Kristina L. Conroy· Nancy M. Espinal· Rachael O. Oyewole
- Observations
- 15
- Pages
- 24
- FEI number
- 1000526875
In short: On August 31, 2021, FDA issued a Form 483 with 15 observations to Teligent, Inc. in Buena, New Jersey (FEI 1000526875) after an inspection that ran Jul 12 – Aug 31, 2021. The investigators were Kristina L. Conroy, Nancy M. Espinal and Rachael O. Oyewole. Most observations concern quality system and laboratory controls; the most-cited regulation is 21 CFR 211.25 (personnel qualifications).
At a glance
Quality system and laboratory controls account for 9 of 15 observations.
Most cited: 21 CFR 211.192 (2×) · 211.25(a) (2×)
What FDA observed
Preview: the opening words of each observation- 01
Investigations of a failure of a batch or any of its components to meet any of…
- 02
Written records are not always made of…
- 03
The written stability testing…
- 04
Drug products do not bear an expiration date determined by appropriate stability data to assure they…
This inspection in context
Kristina L. Conroy
10 documents · 2021–2023
Cites 211.192 (production record review) more than any other section. Most of their documents are for sites in New Jersey.
The firmTeligent, Inc. history
All 6 documents on file for this site, in date order, with what was cited at each inspection.
Similar 483sOther sites cited under 211.192
See how FDA wrote the same problem up elsewhere.
Questions about this 483
What did FDA find at Teligent, Inc.?
FDA listed 15 observations on this Form 483, mostly about quality system, laboratory controls and packaging & labeling. The most-cited regulation is 21 CFR 211.25 (personnel qualifications). The opening words of each observation are shown on this page.
Who inspected Teligent, Inc.?
Kristina L. Conroy, Nancy M. Espinal and Rachael O. Oyewole are named on this Form 483, for the inspection of Jul 12 – Aug 31, 2021. Each investigator has a profile showing what they cite most.
When was Teligent, Inc. inspected by FDA?
The inspection ran Jul 12 – Aug 31, 2021, and the Form 483 is dated August 31, 2021.
How do I get the full Form 483 for Teligent, Inc.?
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