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Form 483

Ecotec Manufacturing, Inc. Form 483, 2023-04-20

FDA issued a Form 483 to Ecotec Manufacturing, Inc. on 2023-04-20 with 4 public-safe observations.

483· Form 483 issuedMedical Devices & Rad Health4 observations

Ecotec Manufacturing, Inc. · Okeechobee, United States · Issued April 20, 2023

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 Apr 2023
21 CFR 820.20(c)

Management review - Lack of or inadequate procedures

Cited by Alex J Wild

20 Apr 2023
21 CFR 820.20(c)

Management review - Lack of or inadequate procedures

Cited by Alex J Wild

20 Apr 2023
21 CFR 820.40

Procedures not adequately established or maintained

Cited by Alex J Wild

20 Apr 2023
21 CFR 820.40

Procedures not adequately established or maintained

Cited by Alex J Wild

Inspected site

EMEcotec Manufacturing, Inc.Okeechobee, United States

Inspection team

AJAlex J Wild

Cited regulations

CFR citations associated with this Form 483.

CitationWhat it coversCited
21 CFR 820.20(c)Cited across public-safe Form 483 observations2x
21 CFR 820.40Cited across public-safe Form 483 observations2x

Source document

PDF
PDF available

Form 483 source document

The source document is available to authorized Atlas users.

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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