Form 483

Alphacaps GmbH Form 483, 2026-03-27

FDA issued a Form 483 to Alphacaps GmbH on 2026-03-27 with 4 public-safe observations.

483· Form 483 issuedFoods & Cosmetics4 observations

Alphacaps GmbH · Augustdorf, Germany · Issued March 27, 2026

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.

27 Mar 2026
21 CFR 111.210

Master manufacturing record - record requirements

Cited by Raymond M Lam

27 Mar 2026
21 CFR 111.70(b)

Specifications - components

Cited by Raymond M Lam

27 Mar 2026
21 CFR 111.70(e)

Specifications - finished dietary supplement

Cited by Raymond M Lam

27 Mar 2026
21 CFR 111.75(a)(1)(i)

Component - verify identity, dietary ingredient

Cited by Raymond M Lam

Inspected site

AGAlphacaps GmbHAugustdorf, Germany

Inspection team

Cited regulations

CFR citations associated with this Form 483.

CitationWhat it coversCited
21 CFR 111.210Cited across public-safe Form 483 observations1x
21 CFR 111.70(b)Cited across public-safe Form 483 observations1x
21 CFR 111.70(e)Cited across public-safe Form 483 observations1x
21 CFR 111.75(a)(1)(i)Cited across public-safe Form 483 observations1x

Full 483 report

Get the verbatim text of all 4 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