Lyophilization Services of New England, Inc. (LSNE), D/B/A: PCI Pharma Services
Form 483 issued November 11, 2020 · Bedford, New Hampshire
- Investigator
- Eales Os
- Observations
- 2
- Pages
- 2
- FEI number
- 3008546445
In short: On November 11, 2020, FDA issued a Form 483 with 2 observations to Lyophilization Services of New England, Inc. (LSNE), D/B/A: PCI Pharma Services in Bedford, New Hampshire (FEI 3008546445). The investigator was Eales Os. Most observations concern facilities & equipment; the most-cited regulation is 21 CFR 211.58 (maintenance).
At a glance
2 of 2 observations on this 483 concern facilities & equipment.
Most cited: 21 CFR 211.58 (1×) · 211.67 (1×)
What FDA observed
Preview: the opening words of each observationDashed: section inferred by FDA Intel and checked against the regulation text
- 01
The GMP non-aseptic manufacturing facility…
- 02
A standard operating procedure used…
This inspection in context
Eales Os
1 document · 2020
Cites 211.58 (maintenance) more than any other section. Most of their documents are for sites in New Hampshire.
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 211.58
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 2 observations on this Form 483, mostly about facilities & equipment. The most-cited regulation is 21 CFR 211.58 (maintenance). 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?
Eales Os 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 November 11, 2020.
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.