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Form 483

Calmo Manufacturing Inc Form 483, 2019-08-23

FDA issued a Form 483 to Calmo Manufacturing Inc on 2019-08-23 with 4 public-safe observations.

483· Form 483 issuedHuman Drugs4 observations

Calmo Manufacturing Inc · Huntington Beach, United States · Issued August 23, 2019

Overview

  • 4 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.

23 Aug 2019
21 CFR 11

Electronic records

Cited by Darren S Brown

23 Aug 2019
21 CFR 211.160(a)

Lab controls established, including changes

Cited by Darren S Brown

23 Aug 2019
21 CFR 211.22(d)

Procedures not in writing, fully followed

Cited by Darren S Brown

23 Aug 2019
21 CFR 211.63

Equipment Design, Size and Location

Cited by Darren S Brown

Inspected site

CMCalmo Manufacturing IncHuntington Beach, United States

Inspection team

DSDarren S Brown

Cited regulations

CFR citations associated with this Form 483.

CitationWhat it coversCited
21 CFR 11Cited across public-safe Form 483 observations1x
21 CFR 211.160(a)Cited across public-safe Form 483 observations1x
21 CFR 211.22(d)Cited across public-safe Form 483 observations1x
21 CFR 211.63Cited across public-safe Form 483 observations1x

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 and every observation in full, 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