Form 483

MANCHESTER VA MEDICAL CENTER Form 483, 2020-01-27

FDA issued a Form 483 to MANCHESTER VA MEDICAL CENTER on 2020-01-27 with 8 public-safe observations.

483· Form 483 issuedHuman Drugs8 observations

MANCHESTER VA MEDICAL CENTER · Manchester, United States · Issued January 27, 2020

Overview

  • 8 public-safe observations are available for this inspection.
  • 1 structured CFR citation is represented.
  • 1 investigator is tied to this Form 483.

Inspectional observations

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

27 Jan 2020
FDCA 501(a)(2)(A)

Actionable microbial contamination, adjacent area

Cited by John P Mistler

27 Jan 2020
FDCA 501(a)(2)(A)

Air flow quality, higher classified area

Cited by John P Mistler

27 Jan 2020
FDCA 501(a)(2)(A)

Ceiling tiles, cleanroom

Cited by John P Mistler

27 Jan 2020
FDCA 501(a)(2)(A)

Disinfecting and cleaning agents, ISO 5 area

Cited by John P Mistler

27 Jan 2020
FDCA 501(a)(2)(A)

Dust-collecting overhangs, surrounding area of ISO 5

Cited by John P Mistler

Inspected site

MVMANCHESTER VA MEDICAL CENTERManchester, United States

Inspection team

Cited regulations

CFR citations associated with this Form 483.

CitationWhat it coversCited
FDCA 501(a)(2)(A)Cited across public-safe Form 483 observations8x

Source document

PDF
PDF available

Form 483 source document

The source document is available to authorized Atlas users.

Full 483 report

Get the verbatim text of all 8 observations

The source PDF, 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