Kobo Products, Inc.
Form 483 issued May 9, 2025 · South Plainfield, New Jersey
- Inspection
- May 2 – May 9, 2025
- Investigator
- Megan Ziegler
- Observations
- 4
- Pages
- 28
- FEI number
- 3003926105
In short: On May 9, 2025, FDA issued a Form 483 with 4 observations to Kobo Products, Inc. in South Plainfield, New Jersey (FEI 3003926105) after an inspection that ran May 2 – May 9, 2025. The investigator was Megan Ziegler. Most observations concern facilities & equipment and production; the most-cited regulation is 21 CFR 211.68 (automatic, mechanical, and electronic equipment).
At a glance
3 of 4 observations on this 483 concern facilities & equipment.
Most cited: 21 CFR 211.68 (2×)
What FDA observed
Preview: the opening words of each observationDashed: section inferred by FDA Intel and checked against the regulation text
- 01
Your firm failed to establish written procedures for production and process controls designed to assure that…
- 02
Routine inspection and checking of automatic, mechanical, and electronic equipment is not performed according to a…
- 03
Equipment and utensils shall be cleaned, maintained, and, as appropriate for the nature of the drug…
- 04
Appropriate controls are not exercised over computers or related systems to prevent unauthorized access…
This inspection in context
Megan Ziegler
7 documents · 2023–2026
Cites 211.113 (control of microbiological contamination) more than any other section. Most of their documents are for sites in North Carolina.
The firmKobo Products, Inc. history
All 2 documents on file for this site, in date order, with what was cited at each inspection.
Similar 483sOther sites cited under 211.68
See how FDA wrote the same problem up elsewhere.
Questions about this 483
What did FDA find at Kobo Products, Inc.?
FDA listed 4 observations on this Form 483, mostly about facilities & equipment and production. The most-cited regulation is 21 CFR 211.68 (automatic, mechanical, and electronic equipment). The opening words of each observation are shown on this page.
Who inspected Kobo Products, Inc.?
Megan Ziegler is named on this Form 483, for the inspection of May 2 – May 9, 2025. Each investigator has a profile showing what they cite most.
When was Kobo Products, Inc. inspected by FDA?
The inspection ran May 2 – May 9, 2025, and the Form 483 is dated May 9, 2025.
How do I get the full Form 483 for Kobo Products, 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.