Atlas

Form 483

Lyophilization Services of New England, Inc. dba PCI Pharma Services Form 483, 2018-12-07

FDA issued a Form 483 to Lyophilization Services of New England, Inc. dba PCI Pharma Services on 2018-12-07 with 4 public-safe observations.

483· Form 483 issuedHuman Drugs4 observations

Lyophilization Services of New England, Inc. dba PCI Pharma Services · Bedford, United States · Issued December 7, 2018

Overview

  • 4 public-safe observations are available for this inspection.
  • 4 structured CFR citations are represented.
  • 2 investigators are tied to this Form 483.

Inspectional observations

Each observation cites the regulation FDA found the firm out of compliance with.

7 Dec 2018
21 CFR 211.113(b)

Procedures for sterile drug products

Cited by Sean R Marcsisin, Robert J Martin

7 Dec 2018
21 CFR 211.192

Investigations of discrepancies, failures

Cited by Sean R Marcsisin, Robert J Martin

7 Dec 2018
21 CFR 211.22(d)

Procedures not in writing, fully followed

Cited by Sean R Marcsisin, Robert J Martin

7 Dec 2018
21 CFR 211.63

Equipment Design, Size and Location

Cited by Sean R Marcsisin, Robert J Martin

Inspected site

LSLyophilization Services of New England, Inc. dba PCI Pharma ServicesBedford, United States

Inspection team

SRSean R Marcsisin
RJRobert J Martin

Cited regulations

CFR citations associated with this Form 483.

CitationWhat it coversCited
21 CFR 211.113(b)Cited across public-safe Form 483 observations1x
21 CFR 211.192Cited across public-safe Form 483 observations1x
21 CFR 211.22(d)Cited across public-safe Form 483 observations1x
21 CFR 211.63Cited across public-safe Form 483 observations1x

Full 483 report

Get the verbatim text of all 4 observations

Every observation in full, so your team sees exactly what was cited and how it was answered.

  • The site's full inspection history around this Form 483
  • Whether these citations escalated to a warning letter
  • The investigators involved and the citations they repeat elsewhere