FDA-Inspected Site

Havix Group Inc

4 FDA inspections are on record for Havix Group Inc in Hoschton, United States.

483· Form 483 issued

Hoschton, United States · Last updated July 10, 2026

Overview

  • 4 FDA inspections are on record.
  • 2 inspections produced a Form 483.
  • The most recent recorded inspection date is 2025-07-25.

At a glance

Inspections

4

Form 483s

2

EIRs

1

Last outcome

Form 483

Inspection history

FDA inspections on record, most recent first.

InspectionCategoryOutcomeForm 483
21 Jul 2025 – 25 Jul 2025Human Drugs483View 483 →
3 Apr 2024 – 9 Apr 2024Human DrugsClean
11 Apr 2022 – 19 Apr 2022Human Drugs483View 483 →
22 Jan 2019 – 30 Jan 2019Human DrugsClean

Observations on record

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

25 Jul 2025
21 CFR 211.110(a)

Control procedures to monitor and validate performance

Cited by Anthony J Donato, Tammy T Brown

25 Jul 2025
21 CFR 211.28(a)

Protective Apparel Not Worn

Cited by Anthony J Donato, Tammy T Brown

25 Jul 2025
21 CFR 211.67(b)(3)

Cleaning SOPs/instructions

Cited by Anthony J Donato, Tammy T Brown

19 Apr 2022
21 CFR 211.113(a)

Procedures for non-sterile drug products

Cited by Susan O Oladeji, Gretchen M Laws

19 Apr 2022
21 CFR 211.68(b)

Computer control of master formula records

Cited by Susan O Oladeji, Gretchen M Laws

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 211.110(a)Cited across public-safe Form 483 observations1x
21 CFR 211.113(a)Cited across public-safe Form 483 observations1x
21 CFR 211.28(a)Cited across public-safe Form 483 observations1x
21 CFR 211.67(b)(3)Cited across public-safe Form 483 observations1x
21 CFR 211.68(b)Cited across public-safe Form 483 observations1x

Full site report

Get the verbatim findings behind Havix Group Inc's 2 Form 483s

Source PDFs 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