Teligent, Inc.
Form 483 issued May 20, 2019 · Buena, New Jersey
- Inspection
- Apr 22 – May 20, 2019
- Investigator
- Nancy M. Espinal
- Observations
- 10
- Pages
- 11
- FEI number
- 1000526875
In short: On May 20, 2019, FDA issued a Form 483 with 10 observations to Teligent, Inc. in Buena, New Jersey (FEI 1000526875) after an inspection that ran Apr 22 – May 20, 2019. The investigator was Nancy M. Espinal. Most observations concern quality system and laboratory controls; the most-cited regulation is 21 CFR 211.165 (testing and release for distribution).
At a glance
Quality system and laboratory controls account for 8 of 10 observations.
Most cited: 21 CFR 211.192 (2×) · 211.180 (2×)
What FDA observed
Preview: the opening words of each observationDashed: section inferred by FDA Intel and checked against the regulation text
- 01
Drug products failing to meet established…
- 02
Investigations of a failure of a batch or any of its components to meet any of…
- 03
Laboratory records are deficient in that they do not include a statement of the results of…
- 04
Written records are not always made of investigations into the failure of a batch or any…
This inspection in context
Nancy M. Espinal
16 documents · 2016–2022
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 10 observations on this Form 483, mostly about quality system, laboratory controls and production. The most-cited regulation is 21 CFR 211.165 (testing and release for distribution). The opening words of each observation are shown on this page.
Who inspected Teligent, Inc.?
Nancy M. Espinal is named on this Form 483, for the inspection of Apr 22 – May 20, 2019. Each investigator has a profile showing what they cite most.
When was Teligent, Inc. inspected by FDA?
The inspection ran Apr 22 – May 20, 2019, and the Form 483 is dated May 20, 2019.
How do I get the full Form 483 for Teligent, Inc.?
Download the original PDF from FDA Intel for $99, with no subscription. Your first Form 483 or letter is on us. You also get an invoice PDF with the order.