Atlas

Form 483

Butternut Brook Farm Form 483, 2011-11-22

FDA issued a Form 483 to Butternut Brook Farm on 2011-11-22 with 2 public-safe observations.

483· Form 483 issued2 observations

Butternut Brook Farm · Kennedy, United States · Issued November 22, 2011

Overview

  • 2 public-safe observations are available for this inspection.
  • 2 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.

22 Nov 2011
21 CFR 530.11(d)

Tissue residue

Cited by Joanne M Schlossin, Andrew M Abramowitz

22 Nov 2011
FDCA 402(a)(4)

Record keeping

Cited by Joanne M Schlossin, Andrew M Abramowitz

Inspected site

BBButternut Brook FarmKennedy, United States

Inspection team

JMJoanne M Schlossin
AMAndrew M Abramowitz

Cited regulations

CFR citations associated with this Form 483.

CitationWhat it coversCited
21 CFR 530.11(d)Cited across public-safe Form 483 observations1x
FDCA 402(a)(4)Cited across public-safe Form 483 observations1x

Full 483 report

Get the verbatim text of all 2 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