FDA-Inspected Site

Amnion LLC

1 FDA inspection is on record for Amnion LLC in Sterling, United States.

483· Form 483 issued

Sterling, United States · Last updated July 12, 2026

Overview

  • 1 FDA inspection is on record.
  • 1 inspection produced a Form 483.
  • The most recent recorded inspection date is 2026-04-08.

At a glance

Inspections

1

Form 483s

1

EIRs

0

Last outcome

Form 483

Inspection history

FDA inspections on record, most recent first.

InspectionCategoryOutcomeForm 483
24 Mar 2026 – 8 Apr 2026Biologics483View 483 →

Observations on record

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

8 Apr 2026
21 CFR 1271.160(b)(5)

Monitoring systems

Cited by La-Tasha M Gunter

8 Apr 2026
21 CFR 1271.190(d)(2)

Documentation of activities

Cited by La-Tasha M Gunter

8 Apr 2026
21 CFR 1271.210(d)(2)

Verification elements

Cited by La-Tasha M Gunter

8 Apr 2026
21 CFR 1271.270(a)

Records maintained concurrently

Cited by La-Tasha M Gunter

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 1271.160(b)(5)Cited across public-safe Form 483 observations1x
21 CFR 1271.190(d)(2)Cited across public-safe Form 483 observations1x
21 CFR 1271.210(d)(2)Cited across public-safe Form 483 observations1x
21 CFR 1271.270(a)Cited across public-safe Form 483 observations1x

Full site report

Get the verbatim findings behind Amnion LLC's 1 Form 483

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