PhannScript LLC
Form 483 issued October 24, 2016 · Somerset, New Jersey
- Inspection
- Oct 4 – Oct 24, 2016
- Investigators
- Liane Krueger· Tonia F. Bernard
- Observations
- 7
- Pages
- 3
- FEI number
- 3012837733
In short: On October 24, 2016, FDA issued a Form 483 with 7 observations to PhannScript LLC in Somerset, New Jersey (FEI 3012837733) after an inspection that ran Oct 4 – Oct 24, 2016. The investigators were Liane Krueger and Tonia F. Bernard. Most observations concern facilities & equipment and production; the most-cited regulation is 21 CFR 211.42 (design and construction features).
At a glance
Facilities & equipment and production account for 6 of 7 observations.
Most cited: 21 CFR 211.42 (2×) · 211.113 (2×)
What FDA observed
Preview: the opening words of each observationDashed: section inferred by FDA Intel and checked against the regulation text
- 01
The ISO 5 classified area is…
- 02
Personnel donned gowning apparel improperly, in a way that may have caused the gowning…
- 03
The ISO 5 (b)(4) was not…
- 04
A HEPA filter in the (b)(4) of the ISO 5 (b)(4) failed airflow testing on (b)(4)…
This inspection in context
Liane Krueger
1 document · 2016
Cites 211.113 (control of microbiological contamination) more than any other section. Most of their documents are for sites in New Jersey.
The firmPhannScript LLC history
All 2 documents on file for this site, in date order, with what was cited at each inspection.
Similar 483sOther sites cited under 211.42
See how FDA wrote the same problem up elsewhere.
Questions about this 483
What did FDA find at PhannScript LLC?
FDA listed 7 observations on this Form 483, mostly about facilities & equipment, production and quality system. The most-cited regulation is 21 CFR 211.42 (design and construction features). The opening words of each observation are shown on this page.
Who inspected PhannScript LLC?
Liane Krueger and Tonia F. Bernard are named on this Form 483, for the inspection of Oct 4 – Oct 24, 2016. Each investigator has a profile showing what they cite most.
When was PhannScript LLC inspected by FDA?
The inspection ran Oct 4 – Oct 24, 2016, and the Form 483 is dated October 24, 2016.
How do I get the full Form 483 for PhannScript LLC?
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.