Lyophilization Services of New England, Inc. (LSNE), D/B/A: PCI Pharma Services
Form 483 issued December 7, 2018 · Bedford, New Hampshire
- Inspection
- Nov 20 – Dec 7, 2018
- Investigators
- Robert J. Martin· Sean R. Marcsisin
- Observations
- 4
- Pages
- 5
- FEI number
- 3008546445
In short: On December 7, 2018, FDA issued a Form 483 with 4 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 Nov 20 – Dec 7, 2018. The investigators were Robert J. Martin and Sean R. Marcsisin. Most observations concern quality system and facilities & equipment.
At a glance
Quality system and facilities & equipment account for 3 of 4 observations.
What FDA observed
Preview: the opening words of each observation- 01
The responsibilities and procedures applicable to the quality control unit…
- 02
Equipment used in the manufacture, processing, packing or holding of drug products is not of appropriate…
- 03
There is a failure to thoroughly review any unexplained discrepancy whether or not the batch…
- 04
Procedures designed to prevent microbiological contamination of drug products purporting to be…
This inspection in context
Robert J. Martin
29 documents · 2014–2023
Cites 211.113 (control of microbiological contamination) 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 211.22(d)
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 4 observations on this Form 483, mostly about quality system, facilities & equipment and production. 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?
Robert J. Martin and Sean R. Marcsisin are named on this Form 483, for the inspection of Nov 20 – Dec 7, 2018. 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 Nov 20 – Dec 7, 2018, and the Form 483 is dated December 7, 2018.
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.