Form 483

Evoqua Water Technologies LLC Form 483, 2024-05-14

FDA issued a Form 483 to Evoqua Water Technologies LLC on 2024-05-14 with 8 public-safe observations.

483· Form 483 issuedMedical Devices & Rad Health8 observations

Evoqua Water Technologies LLC · Buena Park, United States · Issued May 14, 2024

Overview

  • 8 public-safe observations are available for this inspection.
  • 4 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.

14 May 2024
21 CFR 801.20(a)

Label to bear a unique device identifier

Cited by Juanita Banuelos

14 May 2024
21 CFR 801.20(a)

Label to bear a unique device identifier

Cited by Juanita Banuelos

14 May 2024
21 CFR 820.184

DHR content

Cited by Juanita Banuelos

14 May 2024
21 CFR 820.184

DHR content

Cited by Juanita Banuelos

14 May 2024
21 CFR 820.22

Quality Audits - defined intervals

Cited by Juanita Banuelos

Inspected site

EWEvoqua Water Technologies LLCBuena Park, United States

Inspection team

Cited regulations

CFR citations associated with this Form 483.

CitationWhat it coversCited
21 CFR 801.20(a)Cited across public-safe Form 483 observations2x
21 CFR 820.184Cited across public-safe Form 483 observations2x
21 CFR 820.22Cited across public-safe Form 483 observations2x
21 CFR 830.300(a)Cited across public-safe Form 483 observations2x

Source document

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Form 483 source document

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Full 483 report

Get the verbatim text of all 8 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