PhannScript LLC
Form 483 issued August 7, 2018 · Somerset, New Jersey
- Inspection
- Jul 30 – Aug 7, 2018
- Investigators
- Russell J. Glapion· Sena G. Dissmeyer
- Observations
- 4
- Pages
- 3
- FEI number
- 3012837733
In short: On August 7, 2018, FDA issued a Form 483 with 4 observations to PhannScript LLC in Somerset, New Jersey (FEI 3012837733) after an inspection that ran Jul 30 – Aug 7, 2018. The investigators were Russell J. Glapion and Sena G. Dissmeyer. Most observations concern production and facilities & equipment; the most-cited regulation is 21 CFR 211.42 (design and construction features).
At a glance
3 of 4 observations on this 483 concern production.
Most cited: 21 CFR 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
You produced beta-lactam drugs without providing adequate containment, segregation and cleaning of work…
- 02
The use of sporicidal agents in the ISO 5 classified aseptic processing area was inadequate…
- 03
Personnel engaged in aseptic processing were observed with exposed hands, exposed…
- 04
Personnel touched equipment or other surfaces located outside of the ISO 5 classified aseptic processing area…
This inspection in context
Russell J. Glapion
18 documents · 2013–2021
Cites 211.42 (design and construction features) 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 211.113
See how FDA wrote the same problem up elsewhere.
Questions about this 483
What did FDA find at PhannScript LLC?
FDA listed 4 observations on this Form 483, mostly about production and facilities & equipment. 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?
Russell J. Glapion and Sena G. Dissmeyer are named on this Form 483, for the inspection of Jul 30 – Aug 7, 2018. Each investigator has a profile showing what they cite most.
When was PhannScript LLC inspected by FDA?
The inspection ran Jul 30 – Aug 7, 2018, and the Form 483 is dated August 7, 2018.
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.