Lyophilization Services of New England, Inc. (LSNE), D/B/A: PCI Pharma Services
Form 483 issued January 29, 2014 · Bedford, New Hampshire
- Inspection
- Jan 17 – Jan 29, 2014
- Investigators
- Camerson E. Moore· Stacey S. Degarmo
- Observations
- 8
- Pages
- 3
- FEI number
- 3008546445
In short: On January 29, 2014, FDA issued a Form 483 with 8 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 Jan 17 – Jan 29, 2014. The investigators were Camerson E. Moore and Stacey S. Degarmo. Most observations concern facilities & equipment and quality system; the most-cited regulation is 21 CFR 211.67 (equipment cleaning and maintenance).
At a glance
Facilities & equipment and quality system account for 5 of 8 observations.
Most cited: 21 CFR 211.67 (2×)
What FDA observed
Preview: the opening words of each observationDashed: section inferred by FDA Intel and checked against the regulation text
- 01
The Quality unit failed to provide adequate oversight and allowed the following significant changes to be…
- 02
Observation 2: scanned text, readable in the full document.
- 03
The environmental monitoring procedure was revised on 4/9/12 and included the removal of (b) (4) plates…
- 04
Observation 4: scanned text, readable in the full document.
This inspection in context
Camerson E. Moore
48 documents · 2014–2026
Cites 211.113 (control of microbiological contamination) more than any other section. Most of their documents are for sites in Texas.
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 211.67
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 8 observations on this Form 483, mostly about facilities & equipment, quality system and production. The most-cited regulation is 21 CFR 211.67 (equipment cleaning and 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?
Camerson E. Moore and Stacey S. Degarmo are named on this Form 483, for the inspection of Jan 17 – Jan 29, 2014. 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 Jan 17 – Jan 29, 2014, and the Form 483 is dated January 29, 2014.
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.