FDA-Inspected Site

PEARMINE HEALTH LTD

1 FDA inspection is on record for PEARMINE HEALTH LTD in Brackley, United Kingdom.

483· Form 483 issued

Brackley, United Kingdom · 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 2025-09-19.

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
15 Sep 2025 – 19 Sep 2025Human Drugs483View 483 →

Observations on record

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

19 Sep 2025
21 CFR 211.110(a)

Control procedures to monitor and validate performance

Cited by Shanna N Purdy

19 Sep 2025
21 CFR 211.165(a)

Testing and release for distribution

Cited by Shanna N Purdy

19 Sep 2025
21 CFR 211.166(a)

Lack of written stability program

Cited by Shanna N Purdy

19 Sep 2025
21 CFR 211.67(b)

Written procedures not established/followed

Cited by Shanna N Purdy

19 Sep 2025
21 CFR 211.84(d)(2)

Establish reliability of supplier's C of A

Cited by Shanna N Purdy

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 211.110(a)Cited across public-safe Form 483 observations1x
21 CFR 211.165(a)Cited across public-safe Form 483 observations1x
21 CFR 211.166(a)Cited across public-safe Form 483 observations1x
21 CFR 211.67(b)Cited across public-safe Form 483 observations1x
21 CFR 211.84(d)(2)Cited across public-safe Form 483 observations1x

Full site report

Get the verbatim findings behind PEARMINE HEALTH LTD'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