Form 483

J&T Health and Wellness LLC Form 483, 2018-08-24

FDA issued a Form 483 to J&T Health and Wellness LLC on 2018-08-24 with 32 public-safe observations.

483· Form 483 issuedMedical Devices & Rad Health32 observations

J&T Health and Wellness LLC · Saint Petersburg, United States · Issued August 24, 2018

Overview

  • 32 public-safe observations are available for this inspection.
  • 8 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.

24 Aug 2018
21 CFR 803.17

Lack of Written MDR Procedures

Cited by Lisa A Warner

24 Aug 2018
21 CFR 803.17

Lack of Written MDR Procedures

Cited by Lisa A Warner

24 Aug 2018
21 CFR 803.17

Lack of Written MDR Procedures

Cited by Lisa A Warner

24 Aug 2018
21 CFR 803.17

Lack of Written MDR Procedures

Cited by Lisa A Warner

24 Aug 2018
21 CFR 820.100(a)

Lack of or inadequate procedures

Cited by Lisa A Warner

Inspected site

JHJ&T Health and Wellness LLCSaint Petersburg, United States

Inspection team

Cited regulations

CFR citations associated with this Form 483.

CitationWhat it coversCited
21 CFR 803.17Cited across public-safe Form 483 observations4x
21 CFR 820.100(a)Cited across public-safe Form 483 observations4x
21 CFR 820.22Cited across public-safe Form 483 observations4x
21 CFR 820.25(b)Cited across public-safe Form 483 observations4x
21 CFR 820.50Cited across public-safe Form 483 observations4x
21 CFR 820.70(c)Cited across public-safe Form 483 observations4x
21 CFR 820.72(a)Cited across public-safe Form 483 observations4x
21 CFR 820.80(d)Cited across public-safe Form 483 observations4x

Full 483 report

Get the verbatim text of all 32 observations

The full inspection record, as Atlas holds it, 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