Atlas

Form 483

Tools For Surgery, LLC Form 483, 2015-08-27

FDA issued a Form 483 to Tools For Surgery, LLC on 2015-08-27 with 2 public-safe observations.

483· Form 483 issuedMedical Devices & Rad Health2 observations

Tools For Surgery, LLC · Stony Brook, United States · Issued August 27, 2015

Overview

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

27 Aug 2015
21 CFR 820.40(a)

Document review, approval by designated individual

Cited by Andrew J Garufi

27 Aug 2015
21 CFR 820.72(a)

Equipment control activity documentation

Cited by Andrew J Garufi

Inspected site

TFTools For Surgery, LLCStony Brook, United States

Inspection team

AJAndrew J Garufi

Cited regulations

CFR citations associated with this Form 483.

CitationWhat it coversCited
21 CFR 820.40(a)Cited across public-safe Form 483 observations1x
21 CFR 820.72(a)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