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Form 483

QualTech Laboratories, Inc. Form 483, 2026-04-13

FDA issued a Form 483 to QualTech Laboratories, Inc. on 2026-04-13 with 1 public-safe observation.

483· Form 483 issuedHuman Drugs1 observation

QualTech Laboratories, Inc. · Ocean, United States · Issued April 13, 2026

Overview

  • 1 public-safe observation is available for this inspection.
  • 1 structured CFR citation is represented.
  • 1 investigator is tied to this Form 483.

Inspectional observations

Each observation cites the regulation FDA found the firm out of compliance with.

13 Apr 2026
21 CFR 211.194(a)(1)

Sample identification and other information

Cited by Frederick Razzaghi

Inspected site

QLQualTech Laboratories, Inc.Ocean, United States

Inspection team

FRFrederick Razzaghi

Cited regulations

CFR citations associated with this Form 483.

CitationWhat it coversCited
21 CFR 211.194(a)(1)Cited across public-safe Form 483 observations1x

Full 483 report

Get the verbatim text of all 1 observation

The full inspection record, as Atlas holds it, so your team sees exactly what was cited and how it was answered.

  • The site's full inspection history around this Form 483
  • Whether these citations escalated to a warning letter
  • The investigators involved and the citations they repeat elsewhere