Atlas

Form 483

Duy Drugs Inc. Form 483, 2020-03-09

FDA issued a Form 483 to Duy Drugs Inc. on 2020-03-09 with 2 public-safe observations.

483· Form 483 issuedFoods & Cosmetics2 observations

Duy Drugs Inc. · Doral, United States · Issued March 9, 2020

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.

9 Mar 2020
21 CFR 111.70(e)

Specifications - identity, purity, strength, composition

Cited by John J Bernal

9 Mar 2020
21 CFR 111.75(a)(2)(ii)(A)

Component - qualify supplier

Cited by John J Bernal

Inspected site

DDDuy Drugs Inc.Doral, United States

Inspection team

JJJohn J Bernal

Cited regulations

CFR citations associated with this Form 483.

CitationWhat it coversCited
21 CFR 111.70(e)Cited across public-safe Form 483 observations1x
21 CFR 111.75(a)(2)(ii)(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