FDA-Inspected Site

Stira Pharmaceuticals LLC

2 FDA inspections are on record for Stira Pharmaceuticals LLC in Fairfield, United States.

483· Form 483 issued

Fairfield, United States · Last updated August 15, 2026

Overview

  • 2 FDA inspections are on record.
  • 2 inspections produced a Form 483.
  • The most recent recorded inspection date is 2026-04-06.

At a glance

Inspections

2

Form 483s

2

EIRs

1

Last outcome

Form 483

Inspection history

FDA inspections on record, most recent first.

InspectionCategoryOutcomeForm 483
30 Mar 2026 – 6 Apr 2026Human Drugs483View 483 →
27 Oct 2021 – 5 Nov 2021Human Drugs483On file

Observations on record

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

6 Apr 2026
21 CFR 211.160(b)

Scientifically sound laboratory controls

Cited by Unnee Ranjan, Suchan Kim

6 Apr 2026
21 CFR 211.192

Investigations of discrepancies, failures

Cited by Unnee Ranjan, Suchan Kim

6 Apr 2026
21 CFR 211.22(d)

Procedures not in writing, fully followed

Cited by Unnee Ranjan, Suchan Kim

Investigators

FDA investigators tied to this site in the record.

Suchan Kim1 insp.

Recurring citations

CFR citation patterns observed across this site's inspections.

CitationWhat it coversCited
21 CFR 211.160(b)Cited across public-safe Form 483 observations1x
21 CFR 211.192Cited across public-safe Form 483 observations1x
21 CFR 211.22(d)Cited across public-safe Form 483 observations1x

Full site report

Get the verbatim findings behind Stira Pharmaceuticals LLC's 2 Form 483s

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