Drug factory · FDA FEI 3008546445
Lyophilization Services of New England, Inc. (LSNE), D/B/A: PCI Pharma Services
25 Commerce Dr, Bedford, NH, United States
Problems found, fixed voluntarily at FDA's last inspection, Jun 10, 2026.
Voluntary Action Indicated: inspectors found problems, but not serious enough for FDA to take action. The company is expected to fix them.
8 drug inspections on record since 2009: 3 with no problems, 5 with problems fixed voluntarily, 0 with FDA action.
What it does, for whom
| Drug | Role | For | NDC |
|---|---|---|---|
| Octreotide | Makes it | Amryt Pharmaceuticals Designated Activity Company, Chiesi USA, Inc. | 69880-120, 10122-550 |
| Sacrosidase | Makes it | QOL Medical, LLC. | 67871-111 |
| Secretin Human | Makes it | ChiRhoClin, Inc. | 67066-005 |
FDA inspection history
| Ended | Result | Program | Problems noted |
|---|---|---|---|
| Jun 10, 2026 | Problems found, fixed voluntarily | Drug Quality Assurance | — |
| May 24, 2024 | Problems found, fixed voluntarily | Drug Quality Assurance | — |
| Dec 7, 2018 | Problems found, fixed voluntarily | Drug Quality Assurance | 4 |
| Feb 15, 2017 | No problems found | Drug Quality Assurance | — |
| Feb 15, 2017 | No problems found | Drug Quality Assurance | — |
| Apr 24, 2015 | Problems found, fixed voluntarily | Drug Quality Assurance | — |
| Oct 30, 2014 | No problems found | Drug Quality Assurance | — |
| Sep 4, 2009 | Problems found, fixed voluntarily | Drug Quality Assurance | — |
What inspectors wrote down
From FDA's Form 483 citations: conditions an investigator observed that may violate drug manufacturing rules, as FDA published them.
Dec 7, 2018 inspection
- Procedures for sterile drug products 21 CFR 211.113(b)
Procedures designed to prevent microbiological contamination of drug products purporting to be sterile are not established. - Investigations of discrepancies, failures 21 CFR 211.192
There is a failure to thoroughly review any unexplained discrepancy whether or not the batch has been already distributed. - Procedures not in writing, fully followed 21 CFR 211.22(d)
The responsibilities and procedures applicable to the quality control unit are not fully followed. - Equipment Design, Size and Location 21 CFR 211.63
Equipment used in the manufacture, processing, packing or holding of drug products is not of appropriate design to facilitate operations for its intended use and cleaning and maintenance.
Registered with FDA for: manufacture.