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Form 483

Bioelements, Inc Form 483, 2021-10-27

FDA issued a Form 483 to Bioelements, Inc on 2021-10-27 with 7 public-safe observations.

483· Form 483 issuedHuman Drugs7 observations

Bioelements, Inc · Colorado Springs, United States · Issued October 27, 2021

Overview

  • 7 public-safe observations are available for this inspection.
  • 7 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.

27 Oct 2021
21 CFR 211.160(b)

Scientifically sound laboratory controls

Cited by Dogbeda F Mackenzie, Matthew R Clabeaux

27 Oct 2021
21 CFR 211.165(f)

Failing drug products not rejected

Cited by Dogbeda F Mackenzie, Matthew R Clabeaux

27 Oct 2021
21 CFR 211.192

Investigations of discrepancies, failures

Cited by Dogbeda F Mackenzie, Matthew R Clabeaux

27 Oct 2021
21 CFR 211.194(a)(6)

Comparison of Test Results to Specifications

Cited by Dogbeda F Mackenzie, Matthew R Clabeaux

27 Oct 2021
21 CFR 211.22(d)

Procedures not in writing, fully followed

Cited by Dogbeda F Mackenzie, Matthew R Clabeaux

Inspected site

BIBioelements, IncColorado Springs, United States

Inspection team

DFDogbeda F Mackenzie
MRMatthew R Clabeaux

Cited regulations

CFR citations associated with this Form 483.

CitationWhat it coversCited
21 CFR 211.160(b)Cited across public-safe Form 483 observations1x
21 CFR 211.165(f)Cited across public-safe Form 483 observations1x
21 CFR 211.192Cited across public-safe Form 483 observations1x
21 CFR 211.194(a)(6)Cited across public-safe Form 483 observations1x
21 CFR 211.22(d)Cited across public-safe Form 483 observations1x
21 CFR 211.25(a)Cited across public-safe Form 483 observations1x
21 CFR 211.25(b)Cited across public-safe Form 483 observations1x

Source document

PDF
PDF available

Form 483 source document

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Full 483 report

Get the verbatim text of all 7 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