FDA-Inspected Site

Bostal LLC

10 FDA inspections are on record for Bostal LLC in Edison, United States.

483· Form 483 issued

Edison, United States · Last updated July 9, 2026

Overview

  • 10 FDA inspections are on record.
  • 8 inspections produced a Form 483.
  • The most recent recorded inspection date is 2024-12-04.

At a glance

Inspections

10

Form 483s

8

EIRs

0

Last outcome

Form 483

Inspection history

FDA inspections on record, most recent first.

InspectionCategoryOutcomeForm 483
27 Nov 2024 – 4 Dec 2024Human Drugs483View 483 →
22 Mar 2023 – 5 Apr 2023Human Drugs483View 483 →
5 Feb 2019 – 11 Feb 2019Human DrugsClean
14 May 2018 – 23 May 2018Human Drugs483View 483 →
18 Dec 2017 – 5 Jan 2018Human Drugs483View 483 →
14 Jun 2017 – 22 Jun 2017Human Drugs483On file
3 May 2016 – 25 May 2016Human Drugs483On file
5 Dec 2013 – 18 Dec 2013Human Drugs483On file
5 Jun 2012Not recorded483View 483 →
3 Jun 2011Not recordedClean

Observations on record

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

4 Dec 2024
21 CFR 314.80(b)

Failure to develop written procedures

Cited by Michael Serrano

4 Dec 2024
21 CFR 314.80(c)(2)

Late submission of annual safety reports

Cited by Michael Serrano

4 Dec 2024
21 CFR 314.80(c)(2)

Late submission of quarterly safety reports

Cited by Michael Serrano

5 Apr 2023
21 CFR 211.160(b)(4)

Establishment of calibration procedures

Cited by Daniel J Min

5 Apr 2023
21 CFR 211.25(a)

Training--operations, GMPs, written procedures

Cited by Daniel J Min

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 314.80(c)(2)Cited across public-safe Form 483 observations2x
21 CFR 211.110(a)Cited across public-safe Form 483 observations1x
21 CFR 211.160(b)(4)Cited across public-safe Form 483 observations1x
21 CFR 211.192Cited across public-safe Form 483 observations1x
21 CFR 211.25(a)Cited across public-safe Form 483 observations1x
21 CFR 211.67(a)Cited across public-safe Form 483 observations1x
21 CFR 211.67(b)Cited across public-safe Form 483 observations1x
21 CFR 314.80(b)Cited across public-safe Form 483 observations1x

Full site report

Get the verbatim findings behind Bostal LLC's 8 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