Form 483

Southeast Aesthetic LTD Co Form 483, 2013-11-06

FDA issued a Form 483 to Southeast Aesthetic LTD Co on 2013-11-06 with 7 public-safe observations.

483· Form 483 issuedMedical Devices & Rad Health7 observations

Southeast Aesthetic LTD Co · Tallahassee, United States · Issued November 6, 2013

Overview

  • 7 public-safe observations are available for this inspection.
  • 7 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.

6 Nov 2013
21 CFR 803.17

Lack of Written MDR Procedures

Cited by Richard K Vogel

6 Nov 2013
21 CFR 820.22

Quality audits - Lack of or inadequate procedures

Cited by Richard K Vogel

6 Nov 2013
21 CFR 820.30(a)

Design control - no procedures

Cited by Richard K Vogel

6 Nov 2013
21 CFR 820.50

Purchasing controls, Lack of or inadequate procedures

Cited by Richard K Vogel

6 Nov 2013
21 CFR 820.75(a)

Lack of or inadequate process validation

Cited by Richard K Vogel

Inspected site

SASoutheast Aesthetic LTD CoTallahassee, 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 observations1x
21 CFR 820.100(a)Cited across public-safe Form 483 observations1x
21 CFR 820.22Cited across public-safe Form 483 observations1x
21 CFR 820.30(a)Cited across public-safe Form 483 observations1x
21 CFR 820.50Cited across public-safe Form 483 observations1x
21 CFR 820.75(a)Cited across public-safe Form 483 observations1x
21 CFR 820.80(a)Cited across public-safe Form 483 observations1x

Full 483 report

Get the verbatim text of all 7 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