FDA-Inspected Site

Shakti Group, USA, LLC

8 FDA inspections are on record for Shakti Group, USA, LLC in Hamilton, United States.

483· Form 483 issued

Hamilton, United States · Last updated July 10, 2026

Overview

  • 8 FDA inspections are on record.
  • 4 inspections produced a Form 483.
  • The most recent recorded inspection date is 2025-09-08.

At a glance

Inspections

8

Form 483s

4

EIRs

0

Last outcome

Form 483

Inspection history

FDA inspections on record, most recent first.

InspectionCategoryOutcomeForm 483
12 Aug 2025 – 8 Sep 2025Foods & Cosmetics483View 483 →
24 Mar 2025 – 26 Mar 2025Foods & Cosmetics483View 483 →
19 Dec 2024 – 10 Jan 2025Foods & Cosmetics483View 483 →
12 Jul 2022 – 12 Aug 2022Foods & CosmeticsClean
16 Feb 2022 – 22 Feb 2022Foods & Cosmetics483View 483 →
2 Feb 2021 – 8 Mar 2021Foods & CosmeticsClean
11 May 2017Foods & CosmeticsClean
27 Jul 2015 – 28 Jul 2015Foods & CosmeticsClean

Observations on record

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

8 Sep 2025
21 CFR 1.502(a)

Develop FSVP

Cited by Jesse N Nardone

8 Sep 2025
21 CFR 1.504(d)

Document review entity's hazard analysis

Cited by Jesse N Nardone

8 Sep 2025
21 CFR 1.505(a)(2)

Evaluation - performance, risk

Cited by Jesse N Nardone

8 Sep 2025
21 CFR 1.505(b)

Supplier approval - document

Cited by Jesse N Nardone

8 Sep 2025
21 CFR 1.506(a)(1)

Approved supplier procedures - importer established

Cited by Jesse N Nardone

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 117.165(b)Cited across public-safe Form 483 observations3x
21 CFR 1.502(a)Cited across public-safe Form 483 observations2x
21 CFR 1.504(b)(1)Cited across public-safe Form 483 observations1x
21 CFR 1.504(d)Cited across public-safe Form 483 observations1x
21 CFR 1.505(a)(2)Cited across public-safe Form 483 observations1x
21 CFR 1.505(b)Cited across public-safe Form 483 observations1x
21 CFR 1.506(a)(1)Cited across public-safe Form 483 observations1x
21 CFR 1.506(b)Cited across public-safe Form 483 observations1x
21 CFR 1.506(e)(1)Cited across public-safe Form 483 observations1x
21 CFR 1.508(a)Cited across public-safe Form 483 observations1x
21 CFR 1.508(b)Cited across public-safe Form 483 observations1x
21 CFR 117.35(a)Cited across public-safe Form 483 observations1x
21 CFR 117.35(c)Cited across public-safe Form 483 observations1x

Full site report

Get the verbatim findings behind Shakti Group, USA, LLC's 4 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