Atlas

Form 483

Medical Scientific Technologies LLC Form 483, 2014-02-06

FDA issued a Form 483 to Medical Scientific Technologies LLC on 2014-02-06 with 2 public-safe observations.

483· Form 483 issuedHuman Drugs2 observations

Medical Scientific Technologies LLC · Union, United States · Issued February 6, 2014

Overview

  • 2 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.

6 Feb 2014
21 CFR 211.68(b)

Backup file not maintained

Cited by Bonita S Chester

6 Feb 2014
21 CFR 211.160(b)

Scientifically sound laboratory controls

Cited by Bonita S Chester

Inspected site

MSMedical Scientific Technologies LLCUnion, United States

Inspection team

BSBonita S Chester

Cited regulations

CFR citations associated with this Form 483.

CitationWhat it coversCited
21 CFR 211.160(b)Cited across public-safe Form 483 observations1x
21 CFR 211.68(b)Cited across public-safe Form 483 observations1x

Full 483 report

Get the verbatim text of all 2 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