Lyophilization Services of New England, Inc. (LSNE), D/B/A: PCI Pharma Services
Form 483 issued April 19, 2021 · Bedford, New Hampshire
- Investigator
- Wayne Seifert
- Observations
- 3
- Pages
- 2
- FEI number
- 3008546445
In short: On April 19, 2021, FDA issued a Form 483 with 3 observations to Lyophilization Services of New England, Inc. (LSNE), D/B/A: PCI Pharma Services in Bedford, New Hampshire (FEI 3008546445). The investigator was Wayne Seifert. Most observations concern production; the most-cited regulation is 21 CFR 211.100 (written procedures; deviations).
At a glance
Observations span 1 system, led by production.
Most cited: 21 CFR 211.100 (1×)
What FDA observed
Preview: the opening words of each observationDashed: section inferred by FDA Intel and checked against the regulation text
- 01
: of aft The capping pron application 3 vial container closure on ne is i system…
- 02
: Regarding the | Though the equipment…
- 03
A standard operating procedure…
This inspection in context
Wayne Seifert
37 documents · 2010–2025
Cites 211.100 (written procedures; deviations) more than any other section. Most of their documents are for sites in Germany.
The firmLyophilization Services of New England, Inc. (LSNE), D/B/A: PCI Pharma Services history
All 5 documents on file for this site, in date order, with what was cited at each inspection.
Similar 483sOther sites cited under 211.100
See how FDA wrote the same problem up elsewhere.
Questions about this 483
What did FDA find at Lyophilization Services of New England, Inc. (LSNE), D/B/A: PCI Pharma Services?
FDA listed 3 observations on this Form 483, mostly about production. The most-cited regulation is 21 CFR 211.100 (written procedures; deviations). The opening words of each observation are shown on this page.
Who inspected Lyophilization Services of New England, Inc. (LSNE), D/B/A: PCI Pharma Services?
Wayne Seifert is named on this Form 483. Each investigator has a profile showing what they cite most.
When was Lyophilization Services of New England, Inc. (LSNE), D/B/A: PCI Pharma Services inspected by FDA?
This Form 483 is dated April 19, 2021.
How do I get the full Form 483 for Lyophilization Services of New England, Inc. (LSNE), D/B/A: PCI Pharma Services?
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.