Form 483

Happy Farm Botanicals, Inc. Form 483, 2026-04-02

FDA issued a Form 483 to Happy Farm Botanicals, Inc. on 2026-04-02 with 6 public-safe observations.

483· Form 483 issuedHuman Drugs6 observations

Happy Farm Botanicals, Inc. · Hyattsville, United States · Issued April 2, 2026

Overview

  • 6 public-safe observations are available for this inspection.
  • 6 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.

2 Apr 2026
21 CFR 211.100(a)

Absence of Written Procedures

Cited by Kara J Wright

2 Apr 2026
21 CFR 211.160(b)

Scientifically sound laboratory controls

Cited by Kara J Wright

2 Apr 2026
21 CFR 211.166(a)(3)

Valid stability test methods

Cited by Kara J Wright

2 Apr 2026
21 CFR 211.67(a)

Cleaning / Sanitizing / Maintenance

Cited by Kara J Wright

2 Apr 2026
21 CFR 211.67(b)(3)

Cleaning SOPs/instructions

Cited by Kara J Wright

Inspected site

HFHappy Farm Botanicals, Inc.Hyattsville, 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 211.160(b)Cited across public-safe Form 483 observations1x
21 CFR 211.166(a)(3)Cited across public-safe Form 483 observations1x
21 CFR 211.67(a)Cited across public-safe Form 483 observations1x
21 CFR 211.67(b)(3)Cited across public-safe Form 483 observations1x
21 CFR 211.84(d)(1)Cited across public-safe Form 483 observations1x

Full 483 report

Get the verbatim text of all 6 observations

The full inspection record, as Atlas holds it, 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