Atlas

Form 483

NEOLPHARMA, INC. Form 483, 2026-03-10

FDA issued a Form 483 to NEOLPHARMA, INC. on 2026-03-10 with 2 public-safe observations.

483· Form 483 issuedHuman Drugs2 observations

NEOLPHARMA, INC. · Caguas, United States · Issued March 10, 2026

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.

10 Mar 2026
21 CFR 211.22(d)

Procedures not in writing, fully followed

Cited by Angelica M Hernandez

10 Mar 2026
21 CFR 211.56(a)

Sanitation--buildings not clean, free of infestation

Cited by Angelica M Hernandez

Inspected site

NINEOLPHARMA, INC.Caguas, United States

Inspection team

AMAngelica M Hernandez

Cited regulations

CFR citations associated with this Form 483.

CitationWhat it coversCited
21 CFR 211.22(d)Cited across public-safe Form 483 observations1x
21 CFR 211.56(a)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