Kobo Products, Inc.
FDA inspection history in South Plainfield, New Jersey, 2020 to 2025
- 2
- Form 483s
Every document, by year
- Form 483
2020: one Form 483; 2025: one Form 483.
The story so far
Built from the dates and citations on the documents themselves.
- 2020One Form 483, at South Plainfield, New Jersey.
- 2020The longest 483 on file: 6 observations over 5 pages at South Plainfield, New Jersey.
- 2025One Form 483, at South Plainfield, New Jersey.
Cited most
Across all Kobo Products observations on file
- 21 CFR 211.68Automatic, mechanical, and electronic equipment3
- 21 CFR 211.100Written procedures; deviations2
- 21 CFR 211.101Charge-in of components1
- 21 CFR 211.165Testing and release for distribution1
- 21 CFR 211.166Stability testing1
The complete Kobo Products file.
All 2 documents as original PDFs, in one order. For supplier audits, diligence and inspection prep.
The price of the documents, added to your cart together
Sites
South Plainfield, New Jersey
Two Form 483s · 2020 to 2025 · 10 observations
Latest: Form 483, May 9, 2025 →
Documents
2 on file, newest first| Date | Document | Location | Observations | Price |
|---|---|---|---|---|
| 2025-05-09 | 483 Form 483 | South Plainfield, New Jersey | 4 | $99 |
| 2020-08-18 | 483 Form 483 | South Plainfield, New Jersey | 6 | $99 |
Investigators on these documents
FEI number 3003926105 · most recent document May 9, 2025
About Kobo Products, Inc.
How many FDA Form 483s has Kobo Products, Inc. received?
FDA Intel has 2 Form 483s on file for Kobo Products, Inc.; the most recent is dated May 9, 2025.
When was Kobo Products, Inc. last inspected by FDA?
The most recent FDA inspection document on file for Kobo Products, Inc. is a Form 483 dated May 9, 2025, for the site in South Plainfield, New Jersey.
What did FDA cite at Kobo Products, Inc.?
The regulations cited most in the observations on file for Kobo Products, Inc. are 21 CFR 211.68 (Automatic, mechanical, and electronic equipment), 3 times; 21 CFR 211.100 (Written procedures; deviations), 2 times; 21 CFR 211.101 (Charge-in of components), 1 time.