Form 483

Professional Specialties Co Inc Form 483, 2022-10-21

FDA issued a Form 483 to Professional Specialties Co Inc on 2022-10-21 with 16 public-safe observations.

483· Form 483 issuedMedical Devices & Rad Health16 observations

Professional Specialties Co Inc · Memphis, United States · Issued October 21, 2022

Overview

  • 16 public-safe observations are available for this inspection.
  • 4 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.

21 Oct 2022
21 CFR 820.20(c)

Management review dates

Cited by Nikki S Bryant

21 Oct 2022
21 CFR 820.20(c)

Management review dates

Cited by Nikki S Bryant

21 Oct 2022
21 CFR 820.22

Quality Audit/Reaudit - conducted

Cited by Nikki S Bryant

21 Oct 2022
21 CFR 820.22

Quality Audit/Reaudit - conducted

Cited by Nikki S Bryant

21 Oct 2022
21 CFR 820.25(b)

Training records

Cited by Nikki S Bryant

Inspected site

PSProfessional Specialties Co IncMemphis, United States

Inspection team

Cited regulations

CFR citations associated with this Form 483.

CitationWhat it coversCited
21 CFR 820.20(c)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 820.90(b)(2)Cited across public-safe Form 483 observations4x

Source document

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PDF available

Form 483 source document

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Full 483 report

Get the verbatim text of all 16 observations

The source PDF, 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