FDA Intel

Optikem International, Inc.

Form 483 issued March 1, 2024 · Denver, Colorado

Inspection
Feb 26 – Mar 1, 2024
Investigators
Eric C. Fox· Nicholas Z. Lu
Observations
7
Pages
8
FEI number
1720129

In short: On March 1, 2024, FDA issued a Form 483 with 7 observations to Optikem International, Inc. in Denver, Colorado (FEI 1720129) after an inspection that ran Feb 26 – Mar 1, 2024. The investigators were Eric C. Fox and Nicholas Z. Lu. Most observations concern production & process controls and design controls; the most-cited regulation is 21 CFR 820.30 (design controls).

At a glance

Production & process controls and design controls account for 6 of 7 observations.

Production & process controls3
Design controls3
CAPA1

Most cited: 21 CFR 820.30(g) (2×)

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 820.70(c)

    Procedures to control environmental conditions have…

  3. 03
    21 CFR 820.72(a)

    Procedures to ensure equipment is routinely calibrated have…

  4. 04
    21 CFR 820.100(a)

    Procedures for corrective and preventive action have…

3 more observations

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

Get the full 483

This inspection in context

The investigator

Eric C. Fox

3 documents · 2020–2026

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

The firm

Optikem International, Inc. history

All 4 documents on file for this site, in date order, with what was cited at each inspection.

Similar 483s

Other sites cited under 820.30(g)

See how FDA wrote the same problem up elsewhere.

Questions about this 483

What did FDA find at Optikem International, Inc.?

FDA listed 7 observations on this Form 483, mostly about production & process controls, design controls and cAPA. The most-cited regulation is 21 CFR 820.30 (design controls). The opening words of each observation are shown on this page.

Who inspected Optikem International, Inc.?

Eric C. Fox and Nicholas Z. Lu are named on this Form 483, for the inspection of Feb 26 – Mar 1, 2024. Each investigator has a profile showing what they cite most.

When was Optikem International, Inc. inspected by FDA?

The inspection ran Feb 26 – Mar 1, 2024, and the Form 483 is dated March 1, 2024.

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

Download the original PDF from FDA Intel for $99, with no subscription. Your first Form 483 or letter is on us. You also get an invoice PDF with the order.

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