FDA Intel

Cytophil, Inc.

Form 483 issued July 29, 2022 · East Troy, Wisconsin

Inspection
Jul 25 – Jul 29, 2022
Investigator
Nicholas Z. Lu
Observations
5
Pages
6
FEI number
3007225376

In short: On July 29, 2022, FDA issued a Form 483 with 5 observations to Cytophil, Inc. in East Troy, Wisconsin (FEI 3007225376) after an inspection that ran Jul 25 – Jul 29, 2022. The investigator was Nicholas Z. Lu. Most observations concern production & process controls and cAPA.

At a glance

Production & process controls and capa account for 4 of 5 observations.

Production & process controls2
CAPA2
Design controls1

What FDA observed

Preview: the opening words of each observation
  1. 01
    21 CFR 820.75(a)

    A process whose results cannot be fully verified by subsequent inspection and test has not been…

  2. 02
    21 CFR 820.90(a)

    Procedures have not been adequately established to control product that does not…

  3. 03
    21 CFR 820.250(b)

    Procedures to ensure sampling methods are adequate for their intended use have…

  4. 04
    21 CFR 820.100(a)

    Procedures for corrective and preventive action have…

1 more observation

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

Get the full 483

This inspection in context

The investigator

Nicholas Z. Lu

10 documents · 2018–2024

Cites 820.30 (design controls) more than any other section. Most of their documents are for sites in Illinois.

The firm

Cytophil, 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 820.75(a)

See how FDA wrote the same problem up elsewhere.

Questions about this 483

What did FDA find at Cytophil, Inc.?

FDA listed 5 observations on this Form 483, mostly about production & process controls, cAPA and design controls. The opening words of each observation are shown on this page.

Who inspected Cytophil, Inc.?

Nicholas Z. Lu is named on this Form 483, for the inspection of Jul 25 – Jul 29, 2022. Each investigator has a profile showing what they cite most.

When was Cytophil, Inc. inspected by FDA?

The inspection ran Jul 25 – Jul 29, 2022, and the Form 483 is dated July 29, 2022.

How do I get the full Form 483 for Cytophil, Inc.?

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