Atlas

FDA-Inspected Site

Reprolife America, LLC

1 FDA inspection is on record for Reprolife America, LLC in Kingwood, United States.

483· Form 483 issued

Kingwood, 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 2026-03-20.

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
16 Mar 2026 – 20 Mar 2026Medical Devices & Rad Health483View 483 →

Observations on record

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

20 Mar 2026
ISO 13485:2016 Clause 4.1.1

QMS not documented and maintained adequately

Cited by Elizabeth A Krolczyk

20 Mar 2026
ISO 13485:2016 Clause 4.2.3

Medical device file not established and maintained

Cited by Elizabeth A Krolczyk

20 Mar 2026
ISO 13485:2016 Clause 6.4.1

Work environment requirements and procedures not documented

Cited by Elizabeth A Krolczyk

20 Mar 2026
ISO 13485:2016 Clause 7.1

Product realization risk management processes not documented

Cited by Elizabeth A Krolczyk

20 Mar 2026
ISO 13485:2016 Clause 7.3.10

Design and development file does not include or reference required records

Cited by Elizabeth A Krolczyk

Investigators

FDA investigators tied to this site in the record.

Elizabeth A Krolczyk1 insp.

Recurring citations

CFR citation patterns observed across this site's inspections.

CitationWhat it coversCited
ISO 13485:2016 Clause 4.1.1Cited across public-safe Form 483 observations1x
ISO 13485:2016 Clause 4.2.3Cited across public-safe Form 483 observations1x
ISO 13485:2016 Clause 6.4.1Cited across public-safe Form 483 observations1x
ISO 13485:2016 Clause 7.1Cited across public-safe Form 483 observations1x
ISO 13485:2016 Clause 7.3.10Cited across public-safe Form 483 observations1x
ISO 13485:2016 Clause 7.3.9Cited across public-safe Form 483 observations1x
ISO 13485:2016 Clause 7.5.6Cited across public-safe Form 483 observations1x
ISO 13485:2016 Clause 7.5.9.1Cited across public-safe Form 483 observations1x
ISO 13485:2016 Clause 8.2.2Cited across public-safe Form 483 observations1x
ISO 13485:2016 Clause 8.5.2Cited across public-safe Form 483 observations1x

Full site report

Get the verbatim findings behind Reprolife America, 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