Lyophilization Services of New England, Inc. (LSNE), D/B/A: PCI Pharma Services
Form 483 issued September 27, 2023 · Bedford, New Hampshire
- Inspection
- Sep 18 – Sep 27, 2023
- Investigators
- Erik W. Koester· Lane V. Christensen· Samuel J. Arsenault
- Observations
- 9
- Pages
- 13
- FEI number
- 3008546445
In short: On September 27, 2023, FDA issued a Form 483 with 9 observations to Lyophilization Services of New England, Inc. (LSNE), D/B/A: PCI Pharma Services in Bedford, New Hampshire (FEI 3008546445) after an inspection that ran Sep 18 – Sep 27, 2023. The investigators were Erik W. Koester, Lane V. Christensen and Samuel J. Arsenault. Most observations concern facilities & equipment and production.
At a glance
Facilities & equipment and production account for 6 of 9 observations.
What FDA observed
Preview: the opening words of each observationDashed: section inferred by FDA Intel and checked against the regulation text
- 01
Your firm failed to establish adequate written procedures for production and process controls designed to assure…
- 02
Equipment used in the manufacture, processing, packing or holding of drug products is not of appropriate…
- 03
Written procedures are not followed for the cleaning and maintenance of equipment, including utensils, used in…
- 04
Aseptic processing areas are deficient regarding the system for cleaning and disinfecting the room and equipment…
This inspection in context
Erik W. Koester
40 documents · 2006–2026
Cites 211.42 (design and construction features) more than any other section. Most of their documents are for sites in Massachusetts.
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 9 observations on this Form 483, mostly about facilities & equipment, production and quality system. 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?
Erik W. Koester, Lane V. Christensen and Samuel J. Arsenault are named on this Form 483, for the inspection of Sep 18 – Sep 27, 2023. 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?
The inspection ran Sep 18 – Sep 27, 2023, and the Form 483 is dated September 27, 2023.
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.