Form 483

Curia New Mexico, LLC Form 483, 2020-03-20

FDA issued a Form 483 to Curia New Mexico, LLC on 2020-03-20 with 4 public-safe observations.

483· Form 483 issuedHuman Drugs4 observations

Curia New Mexico, LLC · Albuquerque, United States · Issued March 20, 2020

Overview

  • 4 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.

20 Mar 2020
21 CFR 211.113(b)

Procedures for sterile drug products

Cited by Michael A Charles

20 Mar 2020
21 CFR 211.113(b)

Procedures for sterile drug products

Cited by Michael A Charles

20 Mar 2020
21 CFR 211.192

Written record of investigation incomplete

Cited by Michael A Charles

20 Mar 2020
21 CFR 211.192

Written record of investigation incomplete

Cited by Michael A Charles

Inspected site

CNCuria New Mexico, LLCAlbuquerque, United States

Inspection team

Cited regulations

CFR citations associated with this Form 483.

CitationWhat it coversCited
21 CFR 211.113(b)Cited across public-safe Form 483 observations2x
21 CFR 211.192Cited across public-safe Form 483 observations2x

Source document

PDF
PDF available

Form 483 source document

The source document is available to authorized Atlas users.

Full 483 report

Get the verbatim text of all 4 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