Lyophilization Services of New England, Inc. (LSNE), D/B/A: PCI Pharma Services
FDA inspection history in Bedford, New Hampshire, 2014 to 2023
- 5
- Form 483s
Every document, by year
- Form 483
2014: one Form 483; 2018: one Form 483; 2020: one Form 483; 2021: one Form 483; 2023: one Form 483.
The story so far
Built from the dates and citations on the documents themselves.
- 2014One Form 483, at Bedford, New Hampshire.
- 2018–23Four Form 483s, at Bedford, New Hampshire.
- 2023The longest 483 on file: 9 observations over 13 pages at Bedford, New Hampshire.
Cited most
Across all Lyophilization Services of New England, Inc. (LSNE), D/B/A: PCI Pharma Services observations on file
- 21 CFR 211.67Equipment cleaning and maintenance4
- 21 CFR 211.100Written procedures; deviations3
- 21 CFR 211.22Responsibilities of quality control unit3
- 21 CFR 211.160General requirements2
- 21 CFR 211.192Production record review2
The complete Lyophilization Services of New England, Inc. (LSNE), D/B/A: PCI Pharma Services file.
All 5 documents as original PDFs, in one order. For supplier audits, diligence and inspection prep.
15% off buying them one by one
Sites
Bedford, New Hampshire
Five Form 483s · 2014 to 2023 · 21 observations
Latest: Form 483, Sep 27, 2023 →
Documents
5 on file, newest first| Date | Document | Location | Observations | Price |
|---|---|---|---|---|
| 2023-09-27 | 483 Form 483 | Bedford, New Hampshire | 9 | $99 |
| 2021-04-19 | 483 Form 483 | Bedford, New Hampshire | — | $99 |
| 2020-11-11 | 483 Form 483 | Bedford, New Hampshire | — | $99 |
| 2018-12-07 | 483 Form 483 | Bedford, New Hampshire | 4 | $99 |
| 2014-01-29 | 483 Form 483 | Bedford, New Hampshire | 8 | $99 |
Investigators on these documents
Camerson E. Moore (1)Eales Os (1)Erik W. Koester (1)Lane V. Christensen (1)Robert J. Martin (1)Samuel J. Arsenault (1)Sean R. Marcsisin (1)Stacey S. Degarmo (1)Wayne Seifert (1)
FEI number 3008546445 · most recent document Sep 27, 2023
About Lyophilization Services of New England, Inc. (LSNE), D/B/A: PCI Pharma Services
How many FDA Form 483s has Lyophilization Services of New England, Inc. (LSNE), D/B/A: PCI Pharma Services received?
FDA Intel has 5 Form 483s on file for Lyophilization Services of New England, Inc. (LSNE), D/B/A: PCI Pharma Services; the most recent is dated Sep 27, 2023.
When was Lyophilization Services of New England, Inc. (LSNE), D/B/A: PCI Pharma Services last inspected by FDA?
The most recent FDA inspection document on file for Lyophilization Services of New England, Inc. (LSNE), D/B/A: PCI Pharma Services is a Form 483 dated Sep 27, 2023, for the site in Bedford, New Hampshire.
What did FDA cite at Lyophilization Services of New England, Inc. (LSNE), D/B/A: PCI Pharma Services?
The regulations cited most in the observations on file for Lyophilization Services of New England, Inc. (LSNE), D/B/A: PCI Pharma Services are 21 CFR 211.67 (Equipment cleaning and maintenance), 4 times; 21 CFR 211.100 (Written procedures; deviations), 3 times; 21 CFR 211.22 (Responsibilities of quality control unit), 3 times.