Atlas

Form 483

Baystate Medical Center, Inc. Form 483, 2011-08-19

FDA issued a Form 483 to Baystate Medical Center, Inc. on 2011-08-19 with 3 public-safe observations.

483· Form 483 issued3 observations

Baystate Medical Center, Inc. · Springfield, United States · Issued August 19, 2011

Overview

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

Inspectional observations

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

19 Aug 2011
21 CFR 606.100(b)(14)

QC procedures for supplies and reagents

Cited by Alice C Silva

19 Aug 2011
21 CFR 606.100(b)(21)

Donor notification

Cited by Alice C Silva

19 Aug 2011
21 CFR 606.160(a)(1)

Person performing, test results, interpretation

Cited by Alice C Silva

Inspected site

BMBaystate Medical Center, Inc.Springfield, United States

Inspection team

ACAlice C Silva

Cited regulations

CFR citations associated with this Form 483.

CitationWhat it coversCited
21 CFR 606.100(b)(14)Cited across public-safe Form 483 observations1x
21 CFR 606.100(b)(21)Cited across public-safe Form 483 observations1x
21 CFR 606.160(a)(1)Cited across public-safe Form 483 observations1x

Full 483 report

Get the verbatim text of all 3 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