FDA-Inspected Site

STPCA Inc.

7 FDA inspections are on record for STPCA Inc. in Irvine, United States.

483· Form 483 issued

Irvine, United States · Last updated August 15, 2026

Overview

  • 7 FDA inspections are on record.
  • 7 inspections produced a Form 483.
  • The most recent recorded inspection date is 2025-01-24.

At a glance

Inspections

7

Form 483s

7

EIRs

0

Last outcome

Form 483

Inspection history

FDA inspections on record, most recent first.

InspectionCategoryOutcomeForm 483
14 Jan 2025 – 24 Jan 2025Foods & Cosmetics483View 483 →
30 Oct 2023 – 20 Nov 2023Foods & Cosmetics483View 483 →
19 Sep 2022 – 5 Oct 2022Foods & Cosmetics483View 483 →
16 Jun 2021 – 8 Jul 2021Foods & Cosmetics483View 483 →
24 Jul 2018 – 30 Jul 2018Foods & Cosmetics483View 483 →
8 Sep 2015 – 10 Sep 2015Foods & Cosmetics483View 483 →
2 Sep 2011Not recorded483View 483 →

Observations on record

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

24 Jan 2025
21 CFR 111.110

Quality control - Laboratory control processes; production, process control

Cited by Joseph C Yen

24 Jan 2025
21 CFR 111.210

Master manufacturing record - record requirements

Cited by Joseph C Yen

24 Jan 2025
21 CFR 111.260

Batch record - required information

Cited by Joseph C Yen

24 Jan 2025
21 CFR 111.315(d)

Standard reference materials; criteria for selecting

Cited by Joseph C Yen

24 Jan 2025
21 CFR 111.70(b)

Specifications - components

Cited by Joseph C Yen

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 111.70(e)Cited across public-safe Form 483 observations7x
21 CFR 111.70(b)(1)Cited across public-safe Form 483 observations6x
21 CFR 111.70(b)(2)Cited across public-safe Form 483 observations6x
21 CFR 111.105(h)Cited across public-safe Form 483 observations4x
21 CFR 111.75(a)(2)Cited across public-safe Form 483 observations4x
21 CFR 111.75(a)(2)(ii)(A)Cited across public-safe Form 483 observations4x
21 CFR 111.75(c)Cited across public-safe Form 483 observations4x
21 CFR 111.205(b)(2)Cited across public-safe Form 483 observations2x
21 CFR 111.70(c)(1)Cited across public-safe Form 483 observations2x
21 CFR 111.75(a)(1)(i)Cited across public-safe Form 483 observations2x
21 CFR 111.110Cited across public-safe Form 483 observations1x
21 CFR 111.210Cited across public-safe Form 483 observations1x
21 CFR 111.210(b)Cited across public-safe Form 483 observations1x
21 CFR 111.210(f)Cited across public-safe Form 483 observations1x
21 CFR 111.210(g)Cited across public-safe Form 483 observations1x
21 CFR 111.210(h)(2)Cited across public-safe Form 483 observations1x
21 CFR 111.210(h)(5)Cited across public-safe Form 483 observations1x
21 CFR 111.255(c)Cited across public-safe Form 483 observations1x
21 CFR 111.260Cited across public-safe Form 483 observations1x
21 CFR 111.260(j)(2)(iii)Cited across public-safe Form 483 observations1x
21 CFR 111.260(j)(2)(iv)Cited across public-safe Form 483 observations1x
21 CFR 111.30(b)Cited across public-safe Form 483 observations1x
21 CFR 111.315(d)Cited across public-safe Form 483 observations1x
21 CFR 111.70(b)Cited across public-safe Form 483 observations1x
21 CFR 111.70(b)(3)Cited across public-safe Form 483 observations1x
21 CFR 111.70(d)Cited across public-safe Form 483 observations1x
21 CFR 111.80(a)Cited across public-safe Form 483 observations1x

Full site report

Get the verbatim findings behind STPCA Inc.'s 7 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