FDA Intel

Cambrex Charles City, Inc.

Form 483 issued March 7, 2025 · Charles City, Iowa

Observations
3
Pages
11
FEI number
1000119390

In short: On March 7, 2025, FDA issued a Form 483 with 3 observations to Cambrex Charles City, Inc. in Charles City, Iowa (FEI 1000119390). Most observations concern facilities & equipment and quality system.

At a glance

2 of 3 observations on this 483 concern facilities & equipment.

Facilities & equipment2
Quality system1

What FDA observed

Preview: the opening words of each observation

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

  1. 01
    21 CFR 226.3021 CFR 211.67

    Equipment is not maintained in a manner to avoid contamination of Type A medicated articles and…

  2. 02
    21 CFR 211.68

    Appropriate controls are not exercised over computers or related systems to assure that changes in master…

  3. 03
    21 CFR 211.192

    There is a failure to thoroughly review any unexplained discrepancy a failure of a batch or…

The full 483

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

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This inspection in context

The firm

Cambrex Charles City, Inc. history

All 3 documents on file for this site, in date order, with what was cited at each inspection.

Similar 483s

Other sites cited under 211.67

See how FDA wrote the same problem up elsewhere.

Questions about this 483

What did FDA find at Cambrex Charles City, Inc.?

FDA listed 3 observations on this Form 483, mostly about facilities & equipment and quality system. The opening words of each observation are shown on this page.

When was Cambrex Charles City, Inc. inspected by FDA?

This Form 483 is dated March 7, 2025.

How do I get the full Form 483 for Cambrex Charles City, Inc.?

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