Form 483

Micra Biotechnologies Inc Form 483, 2017-04-21

FDA issued a Form 483 to Micra Biotechnologies Inc on 2017-04-21 with 1 public-safe observation.

483· Form 483 issuedHuman Drugs1 observation

Micra Biotechnologies Inc · River Edge, United States · Issued April 21, 2017

Overview

  • 1 public-safe observation is available for this inspection.
  • 1 structured CFR citation is 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 Apr 2017
21 CFR 211.160(a)

Following/documenting laboratory controls

Cited by Tonia F Bernard

Inspected site

MBMicra Biotechnologies IncRiver Edge, United States

Inspection team

Cited regulations

CFR citations associated with this Form 483.

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

Full 483 report

Get the verbatim text of all 1 observation

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