Atlas

Form 483

Apothecon Pharmaceuticals Private Limited Form 483, 2023-07-28

FDA issued a Form 483 to Apothecon Pharmaceuticals Private Limited on 2023-07-28 with 3 public-safe observations.

483· Form 483 issuedMedical Devices & Rad Health3 observations

Apothecon Pharmaceuticals Private Limited · Taluka Padra, Vadodara, India · Issued July 28, 2023

Overview

  • 3 public-safe observations are available for this inspection.
  • 3 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.

28 Jul 2023
21 CFR 820.186

QSR

Cited by Dipesh K Shah

28 Jul 2023
21 CFR 820.30(h)

Design transfer - Lack of or inadequate procedures

Cited by Dipesh K Shah

28 Jul 2023
21 CFR 820.50(a)(2)

Supplier oversight

Cited by Dipesh K Shah

Inspected site

APApothecon Pharmaceuticals Private LimitedTaluka Padra, Vadodara, India

Inspection team

DKDipesh K Shah

Cited regulations

CFR citations associated with this Form 483.

CitationWhat it coversCited
21 CFR 820.186Cited across public-safe Form 483 observations1x
21 CFR 820.30(h)Cited across public-safe Form 483 observations1x
21 CFR 820.50(a)(2)Cited across public-safe Form 483 observations1x

Full 483 report

Get the verbatim text of all 3 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