Kobo Products, Inc.
Form 483 issued August 18, 2020 · South Plainfield, New Jersey
- Inspection
- Aug 18, 2020
- Investigator
- Adetutu Gidado
- Observations
- 6
- Pages
- 5
- FEI number
- 3003926105
In short: On August 18, 2020, FDA issued a Form 483 with 6 observations to Kobo Products, Inc. in South Plainfield, New Jersey (FEI 3003926105) after an inspection that ran Aug 18, 2020. The investigator was Adetutu Gidado. Most observations concern laboratory controls and facilities & equipment; the most-cited regulation is 21 CFR 211.68 (automatic, mechanical, and electronic equipment).
At a glance
Laboratory controls and facilities & equipment account for 4 of 6 observations.
What FDA observed
Preview: the opening words of each observationDashed: section inferred by FDA Intel and checked against the regulation text
- 01
The accuracy, sensitivity, specificity, and reproducibility of test methods have not…
- 02
Appropriate controls are not exercised over computers or related systems to assure that changes in control…
- 03
Laboratory records do not include a complete record of all data secured in the…
- 04
Critical weighing, measuring, and or manufacturing operations is not witnessed or subjected to an equivalent control…
This inspection in context
Adetutu Gidado
16 documents · 2016–2025
Cites 211.68 (automatic, mechanical, and electronic equipment) more than any other section. Most of their documents are for sites in New Jersey.
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 211.165
See how FDA wrote the same problem up elsewhere.
Questions about this 483
What did FDA find at Kobo Products, Inc.?
FDA listed 6 observations on this Form 483, mostly about laboratory controls, 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.?
Adetutu Gidado is named on this Form 483, for the inspection of Aug 18, 2020. Each investigator has a profile showing what they cite most.
When was Kobo Products, Inc. inspected by FDA?
The inspection ran Aug 18, 2020, and the Form 483 is dated August 18, 2020.
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.