SAFC Carlsbad Inc.

Form 483 issued August 14, 2025 · Carlsbad, California

Inspection
Aug 6 – Aug 14, 2025
Observations
1
Pages
3
FEI number
3012673301

In short: On August 14, 2025, FDA issued a Form 483 with 1 observation to SAFC Carlsbad Inc. in Carlsbad, California (FEI 3012673301) after an inspection that ran Aug 6 – Aug 14, 2025. Most observations concern facilities & equipment; the most-cited regulation is 21 CFR 211.67 (equipment cleaning and maintenance).

At a glance

1 of 1 observations on this 483 concern facilities & equipment.

Facilities & equipment1

Most cited: 21 CFR 211.67 (1×) · 211.68 (1×)

What FDA observed

Preview: the opening words of each observation

Dashed: section inferred by FDA Intel and checked against the regulation text

  1. 01

    Failure to follow and/or establish written…

The full 483

Plus the full detail behind each one, exactly as FDA wrote it.

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This inspection in context

Questions about this 483

What did FDA find at SAFC Carlsbad Inc.?

FDA listed 1 observation on this Form 483, mostly about facilities & equipment. The most-cited regulation is 21 CFR 211.67 (equipment cleaning and maintenance). The opening words of each observation are shown on this page.

When was SAFC Carlsbad Inc. inspected by FDA?

The inspection ran Aug 6 – Aug 14, 2025, and the Form 483 is dated August 14, 2025.

How do I get the full Form 483 for SAFC Carlsbad Inc.?

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