Atlas

Form 483

Molecular PharmaGroup LLC Form 483, 2023-12-11

FDA issued a Form 483 to Molecular PharmaGroup LLC on 2023-12-11 with 2 public-safe observations.

483· Form 483 issuedHuman Drugs2 observations

Molecular PharmaGroup LLC · New Providence, United States · Issued December 11, 2023

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.

11 Dec 2023
FDCA 503B(a)(10)(A)

Drug product labels, fails to include

Cited by Helen Verdel

11 Dec 2023
FDCA 503B(b)(2)(A)

All inclusive product report, not submitted

Cited by Helen Verdel

Inspected site

MPMolecular PharmaGroup LLCNew Providence, United States

Inspection team

HVHelen Verdel

Cited regulations

CFR citations associated with this Form 483.

CitationWhat it coversCited
FDCA 503B(a)(10)(A)Cited across public-safe Form 483 observations1x
FDCA 503B(b)(2)(A)Cited across public-safe Form 483 observations1x

Source document

PDF
PDF available

Form 483 source document

The source document is available to authorized Atlas users.

Book a demoStart a free trial

Full 483 report

Get the verbatim text of all 2 observations

The source PDF, 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