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Form 483

Active Medical Form 483, 2019-12-12

FDA issued a Form 483 to Active Medical on 2019-12-12 with 4 public-safe observations.

483· Form 483 issuedBiologics4 observations

Active Medical · Sandy, United States · Issued December 12, 2019

Overview

  • 4 public-safe observations are available for this inspection.
  • 3 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.

12 Dec 2019
21 CFR 1271.170(c)

Trained or re-trained as necessary

Cited by Emily B Camire

12 Dec 2019
21 CFR 1271.180(a)

Procedures to meet core CTGP

Cited by Emily B Camire

12 Dec 2019
21 CFR 1271.260(e)

Periodic review of temperatures

Cited by Emily B Camire

12 Dec 2019
21 CFR 1271.260(e)

Storage temperatures recorded, maintained

Cited by Emily B Camire

Inspected site

AMActive MedicalSandy, United States

Inspection team

EBEmily B Camire

Cited regulations

CFR citations associated with this Form 483.

CitationWhat it coversCited
21 CFR 1271.260(e)Cited across public-safe Form 483 observations2x
21 CFR 1271.170(c)Cited across public-safe Form 483 observations1x
21 CFR 1271.180(a)Cited 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, 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