Atlas

FDA-Inspected Site

Lyophilization Services of New England, Inc. dba PCI Pharma Services

10 FDA inspections are on record for Lyophilization Services of New England, Inc. dba PCI Pharma Services in Bedford, United States.

483· Form 483 issued

Bedford, United States · Last updated July 9, 2026

Overview

  • 10 FDA inspections are on record.
  • 8 inspections produced a Form 483.
  • The most recent recorded inspection date is 2026-06-10.

At a glance

Inspections

10

Form 483s

8

EIRs

2

Last outcome

Form 483

Inspection history

FDA inspections on record, most recent first.

InspectionCategoryOutcomeForm 483
27 May 2026 – 10 Jun 2026Human Drugs483View 483 →
13 May 2024 – 24 May 2024Human Drugs483View 483 →
18 Sep 2023 – 27 Sep 2023Human Drugs483View 483 →
15 Apr 2021 – 19 Apr 2021Biologics483On file
5 Nov 2020 – 11 Nov 2020Biologics483On file
20 Nov 2018 – 7 Dec 2018Human Drugs483View 483 →
1 Feb 2017 – 15 Feb 2017Human DrugsClean
23 Jan 2017 – 15 Feb 2017Human DrugsClean
13 Apr 2015 – 24 Apr 2015Human Drugs483View 483 →
14 Jan 2014 – 29 Jan 2014Human Drugs483On file

Observations on record

Form 483 observations cited at this site, most recent first.

10 Jun 2026
21 CFR 211.100(a)

Absence of Written Procedures

Cited by Wayne E Seifert, Daniel L Zheng, Ogechi C Nna, Armen H Youssoufian, Talia A Faison

10 Jun 2026
21 CFR 211.113(b)

Procedures for sterile drug products

Cited by Wayne E Seifert, Daniel L Zheng, Ogechi C Nna, Armen H Youssoufian, Talia A Faison

10 Jun 2026
21 CFR 211.192

Investigations of discrepancies, failures

Cited by Wayne E Seifert, Daniel L Zheng, Ogechi C Nna, Armen H Youssoufian, Talia A Faison

10 Jun 2026
21 CFR 211.58

Buildings not maintained in good state of repair

Cited by Wayne E Seifert, Daniel L Zheng, Ogechi C Nna, Armen H Youssoufian, Talia A Faison

10 Jun 2026
21 CFR 211.63

Equipment Design, Size and Location

Cited by Wayne E Seifert, Daniel L Zheng, Ogechi C Nna, Armen H Youssoufian, Talia A Faison

Investigators

FDA investigators tied to this site in the record.

Wayne E Seifert3 insp.
Sean R Marcsisin3 insp.
Erik W Koester3 insp.
Robert J Martin3 insp.
John P Mistler3 insp.
Stacey S Degarmo2 insp.
Daniel L Zheng1 insp.
Ogechi C Nna1 insp.
Armen H Youssoufian1 insp.
Talia A Faison1 insp.
Karishma G Gopaul1 insp.
Lane V Christensen1 insp.
Samuel J Arsenault1 insp.
Maotang Zhou1 insp.
Camerson E Moore1 insp.

Recurring citations

CFR citation patterns observed across this site's inspections.

CitationWhat it coversCited
21 CFR 211.192Cited across public-safe Form 483 observations6x
21 CFR 211.113(b)Cited across public-safe Form 483 observations4x
21 CFR 211.160(a)Cited across public-safe Form 483 observations3x
21 CFR 211.63Cited across public-safe Form 483 observations3x
21 CFR 211.67(a)Cited across public-safe Form 483 observations3x
21 CFR 211.100(a)Cited across public-safe Form 483 observations2x
21 CFR 211.103Cited across public-safe Form 483 observations2x
21 CFR 211.22(d)Cited across public-safe Form 483 observations2x
21 CFR 211.42(c)(10)(iv)Cited across public-safe Form 483 observations2x
21 CFR 211.58Cited across public-safe Form 483 observations2x
21 CFR 211.42(c)(10)(v)Cited across public-safe Form 483 observations1x
21 CFR 211.56(a)Cited across public-safe Form 483 observations1x
21 CFR 211.67(b)Cited across public-safe Form 483 observations1x
21 CFR 211.84(d)(3)Cited across public-safe Form 483 observations1x

Full site report

Get the verbatim findings behind this site's 8 Form 483s

Source PDFs, verbatim observations, and recurring CFR citations, so your team knows what this site gets cited for.

  • The site's full inspection history, with every Form 483 and its outcome
  • Warning letters and recalls tied to the company behind it
  • Whether recurring CFR citations get closed out or repeat