Teligent, Inc.
Form 483 issued October 19, 2017 · Buena, New Jersey
- Inspection
- Oct 2 – Oct 19, 2017
- Investigator
- Nancy M. Espinal
- Observations
- 6
- Pages
- 4
- FEI number
- 1000526875
In short: On October 19, 2017, FDA issued a Form 483 with 6 observations to Teligent, Inc. in Buena, New Jersey (FEI 1000526875) after an inspection that ran Oct 2 – Oct 19, 2017. The investigator was Nancy M. Espinal. Most observations concern laboratory controls and materials; the most-cited regulation is 21 CFR 211.165 (testing and release for distribution).
At a glance
4 of 6 observations on this 483 concern laboratory controls.
Most cited: 21 CFR 211.165 (2×) · 211.160 (2×)
What FDA observed
Preview: the opening words of each observationDashed: section inferred by FDA Intel and checked against the regulation text
- 01
There was a failure to handle materials in a…
- 02
Investigation into failures are not performed…
- 03
The suitability of microbiology test methods…
- 04
Testing and release of drug product do not include appropriate laboratory determination of satisfactory conformance…
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 211.165
See how FDA wrote the same problem up elsewhere.
Questions about this 483
What did FDA find at Teligent, Inc.?
FDA listed 6 observations on this Form 483, mostly about laboratory controls, materials and quality system. 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 Oct 2 – Oct 19, 2017. Each investigator has a profile showing what they cite most.
When was Teligent, Inc. inspected by FDA?
The inspection ran Oct 2 – Oct 19, 2017, and the Form 483 is dated October 19, 2017.
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.