Atlas

FDA-Inspected Site

Oral Biotech LLC

4 FDA inspections are on record for Oral Biotech LLC in Albany, United States.

483· Form 483 issued

Albany, United States · Last updated July 10, 2026

Overview

  • 4 FDA inspections are on record.
  • 3 inspections produced a Form 483.
  • The most recent recorded inspection date is 2024-10-24.

At a glance

Inspections

4

Form 483s

3

EIRs

0

Last outcome

Form 483

Inspection history

FDA inspections on record, most recent first.

InspectionCategoryOutcomeForm 483
21 Oct 2024 – 24 Oct 2024Human Drugs483View 483 →
27 Sep 2022Foods & CosmeticsClean
19 Jun 2018 – 22 Jun 2018Medical Devices & Rad Health483On file
1 Apr 2015 – 2 Apr 2015Medical Devices & Rad Health483View 483 →

Observations on record

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

24 Oct 2024
21 CFR 211.110(a)

Control procedures to monitor and validate performance

Cited by Cecilia H Kieu, Jason K Loo

24 Oct 2024
21 CFR 211.22(d)

Procedures not in writing, fully followed

Cited by Cecilia H Kieu, Jason K Loo

24 Oct 2024
21 CFR 211.42(a)

Buildings of Suitable Size, Construction, Location

Cited by Cecilia H Kieu, Jason K Loo

24 Oct 2024
21 CFR 211.63

Equipment Design, Size and Location

Cited by Cecilia H Kieu, Jason K Loo

2 Apr 2015
21 CFR 820.181

DMR - not or inadequately maintained

Cited by Sharon I Gundersen

Investigators

FDA investigators tied to this site in the record.

Cecilia H Kieu1 insp.
Jason K Loo1 insp.
Patrick R Brown1 insp.
James D Hildreth1 insp.
Sharon I Gundersen1 insp.

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 211.22(d)Cited across public-safe Form 483 observations1x
21 CFR 211.42(a)Cited across public-safe Form 483 observations1x
21 CFR 211.63Cited across public-safe Form 483 observations1x
21 CFR 820.181Cited across public-safe Form 483 observations1x
21 CFR 820.20(c)Cited across public-safe Form 483 observations1x
21 CFR 820.22Cited across public-safe Form 483 observations1x
21 CFR 820.40Cited across public-safe Form 483 observations1x
21 CFR 820.90(a)Cited across public-safe Form 483 observations1x

Full site report

Get the verbatim findings behind Oral Biotech LLC's 3 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