Form 483

SAALT, LLC Form 483, 2019-03-08

FDA issued a Form 483 to SAALT, LLC on 2019-03-08 with 8 public-safe observations.

483· Form 483 issuedMedical Devices & Rad Health8 observations

SAALT, LLC · Boise, United States · Issued March 8, 2019

Overview

  • 8 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.

8 Mar 2019
21 CFR 820.198(c)

Investigation of device failures

Cited by Babatunde D Babalola

8 Mar 2019
21 CFR 820.198(c)

Investigation of device failures

Cited by Babatunde D Babalola

8 Mar 2019
21 CFR 820.25(b)

Training records

Cited by Babatunde D Babalola

8 Mar 2019
21 CFR 820.25(b)

Training records

Cited by Babatunde D Babalola

8 Mar 2019
21 CFR 820.198(c)

Investigation of device failures

Cited by Babatunde D Babalola

Inspected site

SLSAALT, LLCBoise, United States

Inspection team

Cited regulations

CFR citations associated with this Form 483.

CitationWhat it coversCited
21 CFR 820.198(c)Cited across public-safe Form 483 observations4x
21 CFR 820.25(b)Cited across public-safe Form 483 observations4x

Full 483 report

Get the verbatim text of all 8 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