Atlas

Form 483

South Bend Medical Foundation, Inc. Form 483, 2018-11-09

FDA issued a Form 483 to South Bend Medical Foundation, Inc. on 2018-11-09 with 1 public-safe observation.

483· Form 483 issuedBiologics1 observation

South Bend Medical Foundation, Inc. · Goshen, United States · Issued November 9, 2018

Overview

  • 1 public-safe observation is 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.

9 Nov 2018
21 CFR 606.60(a)

Equipment observed, standardized, calibrated

Cited by Travis S Bradley

Inspected site

SBSouth Bend Medical Foundation, Inc.Goshen, United States

Inspection team

TSTravis S Bradley

Cited regulations

CFR citations associated with this Form 483.

CitationWhat it coversCited
21 CFR 606.60(a)Cited across public-safe Form 483 observations1x

Full 483 report

Get the verbatim text of all 1 observation

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