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Form 483

Omega & Delta Co., Inc. Form 483, 2023-10-23

FDA issued a Form 483 to Omega & Delta Co., Inc. on 2023-10-23 with 3 public-safe observations.

483· Form 483 issuedHuman Drugs3 observations

Omega & Delta Co., Inc. · Carolina, United States · Issued October 23, 2023

Overview

  • 3 public-safe observations are available for this inspection.
  • 3 structured CFR citations are represented.
  • 2 investigators are tied to this Form 483.

Inspectional observations

Each observation cites the regulation FDA found the firm out of compliance with.

23 Oct 2023
21 CFR 211.100(a)

Absence of Written Procedures

Cited by Marian E Ramirez, Alan A Rivera

23 Oct 2023
21 CFR 211.166(a)

Written program not followed

Cited by Marian E Ramirez, Alan A Rivera

23 Oct 2023
21 CFR 211.22(a)

Lack of quality control unit

Cited by Marian E Ramirez, Alan A Rivera

Inspected site

O&Omega & Delta Co., Inc.Carolina, United States

Inspection team

MEMarian E Ramirez
AAAlan A Rivera

Cited regulations

CFR citations associated with this Form 483.

CitationWhat it coversCited
21 CFR 211.100(a)Cited across public-safe Form 483 observations1x
21 CFR 211.166(a)Cited across public-safe Form 483 observations1x
21 CFR 211.22(a)Cited across public-safe Form 483 observations1x

Source document

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Form 483 source document

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Full 483 report

Get the verbatim text of all 3 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