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Form 483

Biocare Medical, LLC Form 483, 2015-04-27

FDA issued a Form 483 to Biocare Medical, LLC on 2015-04-27 with 6 public-safe observations.

483· Form 483 issuedMedical Devices & Rad Health6 observations

Biocare Medical, LLC · Concord, United States · Issued April 27, 2015

Overview

  • 6 public-safe observations are available for this inspection.
  • 3 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 Apr 2015
21 CFR 806.10(a)(1)

Report of risk to health

Cited by Adam S Freeman

27 Apr 2015
21 CFR 820.100(a)

Lack of or inadequate procedures

Cited by Adam S Freeman

27 Apr 2015
21 CFR 820.20(b)

Lack of or inadequate organizational structure

Cited by Adam S Freeman

27 Apr 2015
21 CFR 806.10(a)(1)

Report of risk to health

Cited by Adam S Freeman

27 Apr 2015
21 CFR 820.100(a)

Lack of or inadequate procedures

Cited by Adam S Freeman

Inspected site

BMBiocare Medical, LLCConcord, United States

Inspection team

ASAdam S Freeman

Cited regulations

CFR citations associated with this Form 483.

CitationWhat it coversCited
21 CFR 806.10(a)(1)Cited across public-safe Form 483 observations2x
21 CFR 820.100(a)Cited across public-safe Form 483 observations2x
21 CFR 820.20(b)Cited across public-safe Form 483 observations2x

Source document

PDF
PDF available

Form 483 source document

The source document is available to authorized Atlas users.

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Full 483 report

Get the verbatim text of all 6 observations

The source PDF and 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