Form 483

Skytronics Led, Inc Form 483, 2026-01-12

FDA issued a Form 483 to Skytronics Led, Inc on 2026-01-12 with 7 public-safe observations.

483· Form 483 issuedHuman Drugs7 observations

Skytronics Led, Inc · Burbank, United States · Issued January 12, 2026

Overview

  • 7 public-safe observations are available for this inspection.
  • 7 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 Jan 2026
21 CFR 211.100(a)

Approval and review of procedures

Cited by Bryan L Mcguckin

12 Jan 2026
21 CFR 211.165(a)

Testing and release for distribution

Cited by Bryan L Mcguckin

12 Jan 2026
21 CFR 211.166(a)

Lack of written stability program

Cited by Bryan L Mcguckin

12 Jan 2026
21 CFR 211.194(a)(6)

Comparison of Test Results to Specifications

Cited by Bryan L Mcguckin

12 Jan 2026
21 CFR 211.22(a)

Lack of quality control unit

Cited by Bryan L Mcguckin

Inspected site

SLSkytronics Led, IncBurbank, United States

Inspection team

Cited regulations

CFR citations associated with this Form 483.

CitationWhat it coversCited
21 CFR 211.100(a)Cited across public-safe Form 483 observations1x
21 CFR 211.165(a)Cited across public-safe Form 483 observations1x
21 CFR 211.166(a)Cited across public-safe Form 483 observations1x
21 CFR 211.194(a)(6)Cited across public-safe Form 483 observations1x
21 CFR 211.22(a)Cited across public-safe Form 483 observations1x
21 CFR 211.67(b)Cited across public-safe Form 483 observations1x
21 CFR 211.84(d)(3)Cited across public-safe Form 483 observations1x

Source document

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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