FDA-Inspected Site

Micra Biotechnologies Inc

9 FDA inspections are on record for Micra Biotechnologies Inc in River Edge, United States.

483· Form 483 issued

River Edge, United States · Last updated July 9, 2026

Overview

  • 9 FDA inspections are on record.
  • 5 inspections produced a Form 483.
  • The most recent recorded inspection date is 2024-08-02.

At a glance

Inspections

9

Form 483s

5

EIRs

2

Last outcome

Form 483

Inspection history

FDA inspections on record, most recent first.

InspectionCategoryOutcomeForm 483
29 Jul 2024 – 2 Aug 2024Human Drugs483View 483 →
17 Apr 2017 – 21 Apr 2017Human Drugs483View 483 →
3 Mar 2015 – 10 Mar 2015Human Drugs483View 483 →
26 Feb 2013 – 4 Mar 2013Human Drugs483View 483 →
30 Jan 2012Not recorded483View 483 →
23 Jul 2010Not recordedClean
23 Apr 2008Not recordedClean
21 Feb 2003Not recordedClean
25 Sep 2001Not recordedClean

Observations on record

Form 483 observations cited at this site, most recent first.

2 Aug 2024
21 CFR 211.160(a)

Following/documenting laboratory controls

Cited by Juanita P Versace

2 Aug 2024
21 CFR 211.160(b)

Scientifically sound laboratory controls

Cited by Juanita P Versace

2 Aug 2024
21 CFR 211.22(d)

Procedures not in writing, fully followed

Cited by Juanita P Versace

2 Aug 2024
21 CFR 211.25(a)

GMP Training Frequency

Cited by Juanita P Versace

2 Aug 2024
21 CFR 211.42(c)(9)

Control / Lab Operations Area

Cited by Juanita P Versace

Investigators

FDA investigators tied to this site in the record.

Recurring citations

CFR citation patterns observed across this site's inspections.

CitationWhat it coversCited
21 CFR 211.160(a)Cited across public-safe Form 483 observations4x
21 CFR 211.25(a)Cited across public-safe Form 483 observations4x
21 CFR 211.194(a)(2)Cited across public-safe Form 483 observations2x
21 CFR 211.22(d)Cited across public-safe Form 483 observations2x
21 CFR 211.160(b)Cited across public-safe Form 483 observations1x
21 CFR 211.194(a)(8)Cited across public-safe Form 483 observations1x
21 CFR 211.42(c)(9)Cited across public-safe Form 483 observations1x

Full site report

Get the verbatim findings behind Micra Biotechnologies Inc's 5 Form 483s

Source PDFs, verbatim observations, and recurring CFR citations, so your team knows what this site gets cited for.

  • The site's full inspection history, with every Form 483 and its outcome
  • Warning letters and recalls tied to the company behind it
  • Whether recurring CFR citations get closed out or repeat