FDA-Inspected Site

Tekweld Solutions, Inc.

3 FDA inspections are on record for Tekweld Solutions, Inc. in Hauppauge, United States.

483· Form 483 issued

Hauppauge, United States · Last updated July 11, 2026

Overview

  • 3 FDA inspections are on record.
  • 3 inspections produced a Form 483.
  • The most recent recorded inspection date is 2025-01-16.

At a glance

Inspections

3

Form 483s

3

EIRs

0

Last outcome

Form 483

Inspection history

FDA inspections on record, most recent first.

InspectionCategoryOutcomeForm 483
13 Jan 2025 – 16 Jan 2025Human Drugs483View 483 →
13 Jan 2020 – 17 Jan 2020Human Drugs483View 483 →
22 Aug 2019Foods & Cosmetics483On file

Observations on record

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

16 Jan 2025
21 CFR 211.22(a)

Lack of quality control unit

Cited by Stephenie M Ortiz

16 Jan 2025
21 CFR 211.46(b)

Equipment for Environmental Control

Cited by Stephenie M Ortiz

16 Jan 2025
21 CFR 211.84(d)(2)

Establish reliability of supplier's C of A

Cited by Stephenie M Ortiz

17 Jan 2020
21 CFR 211.122(a)

Written procedures describing in detail

Cited by Rachael A Moliver

17 Jan 2020
21 CFR 211.125(c)

Label reconciliation discrepancies evaluation/investigation

Cited by Rachael A Moliver

Investigators

FDA investigators tied to this site in the record.

State Agency1 insp.

Recurring citations

CFR citation patterns observed across this site's inspections.

CitationWhat it coversCited
21 CFR 211.22(a)Cited across public-safe Form 483 observations2x
21 CFR 211.122(a)Cited across public-safe Form 483 observations1x
21 CFR 211.125(c)Cited across public-safe Form 483 observations1x
21 CFR 211.130(e)Cited across public-safe Form 483 observations1x
21 CFR 211.25(a)Cited across public-safe Form 483 observations1x
21 CFR 211.46(b)Cited across public-safe Form 483 observations1x
21 CFR 211.84(d)(2)Cited across public-safe Form 483 observations1x

Full site report

Get the verbatim findings behind Tekweld Solutions, Inc.'s 3 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