FDA-Inspected Site

Bora Pharmaceuticals Laboratories, Inc

7 FDA inspections are on record for Bora Pharmaceuticals Laboratories, Inc in Miaoli County, Taiwan.

483· Form 483 issued

Miaoli County, Taiwan · Last updated July 9, 2026

Overview

  • 7 FDA inspections are on record.
  • 4 inspections produced a Form 483.
  • The most recent recorded inspection date is 2025-07-21.

At a glance

Inspections

7

Form 483s

4

EIRs

0

Last outcome

Form 483

Inspection history

FDA inspections on record, most recent first.

InspectionCategoryOutcomeForm 483
15 Jul 2025 – 21 Jul 2025Human Drugs483On file
20 May 2019 – 24 May 2019Human DrugsClean
13 Feb 2017 – 17 Feb 2017Human DrugsClean
11 Apr 2016 – 15 Apr 2016Human Drugs483View 483 →
21 Jul 2014 – 26 Jul 2014Human Drugs483On file
26 Jul 2012Not recordedClean
18 Jun 2009Not recorded483On file

Observations on record

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

15 Apr 2016
21 CFR 211.166(a)

Written program not followed

Cited by Pratik S Upadhyay

15 Apr 2016
21 CFR 211.110(a)

Control procedures to monitor and validate performance

Cited by Pratik S Upadhyay

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 211.166(a)Cited across public-safe Form 483 observations1x

Full site report

Get the verbatim findings behind Bora Pharmaceuticals Laboratories, Inc's 4 Form 483s

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