Teligent, Inc.
Form 483 issued March 8, 2011 · Buena, New Jersey
- Inspection
- Mar 2 – Mar 8, 2011
- Investigator
- Paul L. Bellamy
- Observations
- 1
- Pages
- 1
- FEI number
- 1000526875
In short: On March 8, 2011, FDA issued a Form 483 with 1 observation to Teligent, Inc. in Buena, New Jersey (FEI 1000526875) after an inspection that ran Mar 2 – Mar 8, 2011. The investigator was Paul L. Bellamy. Most observations concern quality system; the most-cited regulation is 21 CFR 211.25 (personnel qualifications).
At a glance
1 of 1 observations on this 483 concern quality system.
Most cited: 21 CFR 211.25(a) (1×)
What FDA observed
Preview: the opening words of each observation- 01
Employees engaged in the processing of a drug product lack the education, training, and experience required…
This inspection in context
Paul L. Bellamy
4 documents · 2011–2016
Cites 211.113(b) (control of microbiological contamination) 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 211.25(a)
See how FDA wrote the same problem up elsewhere.
Questions about this 483
What did FDA find at Teligent, Inc.?
FDA listed 1 observation on this Form 483, mostly about quality system. 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.?
Paul L. Bellamy is named on this Form 483, for the inspection of Mar 2 – Mar 8, 2011. Each investigator has a profile showing what they cite most.
When was Teligent, Inc. inspected by FDA?
The inspection ran Mar 2 – Mar 8, 2011, and the Form 483 is dated March 8, 2011.
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.