Atlas

Form 483

Thurs Organics Private Limited Form 483, 2025-09-19

FDA issued a Form 483 to Thurs Organics Private Limited on 2025-09-19 with 2 public-safe observations.

483· Form 483 issuedHuman Drugs2 observations

Thurs Organics Private Limited · Ratnagiri, India · Issued September 19, 2025

Overview

  • 2 public-safe observations are available for this inspection.
  • 2 structured CFR citations are represented.
  • 1 investigator is tied to this Form 483.

Inspectional observations

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

19 Sep 2025
21 CFR 211.188

Prepared for each batch, include complete information

Cited by Jared P Stevens

19 Sep 2025
21 CFR 211.22(d)

Procedures not in writing, fully followed

Cited by Jared P Stevens

Inspected site

TOThurs Organics Private LimitedRatnagiri, India

Inspection team

JPJared P Stevens

Cited regulations

CFR citations associated with this Form 483.

CitationWhat it coversCited
21 CFR 211.188Cited across public-safe Form 483 observations1x
21 CFR 211.22(d)Cited across public-safe Form 483 observations1x

Full 483 report

Get the verbatim text of all 2 observations

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