Products By 02, Inc.
Form 483 issued October 23, 2023 · Boynton Beach, Florida
- Inspection
- Oct 17 – Oct 23, 2023
- Investigator
- Steven A. Brettler
- Observations
- 1
- Pages
- 10
In short: On October 23, 2023, FDA issued a Form 483 with 1 observation to Products By 02, Inc. in Boynton Beach, Florida after an inspection that ran Oct 17 – Oct 23, 2023. The investigator was Steven A. Brettler. Most observations concern materials; the most-cited regulation is 21 CFR 211.84 (testing and approval or rejection of components, drug product containers, and closures).
At a glance
1 of 1 observations on this 483 concern materials.
Most cited: 21 CFR 211.84 (1×)
What FDA observed
Preview: the opening words of each observationDashed: section inferred by FDA Intel and checked against the regulation text
- 01
Specific identification tests are not conducted on components that have been accepted based on the…
This inspection in context
Steven A. Brettler
15 documents · 2021–2026
Cites 211.100 (written procedures; deviations) more than any other section. Most of their documents are for sites in Florida.
The firmProducts By 02, Inc. history
The site's inspection history, in date order.
Similar 483sOther sites cited under 211.84
See how FDA wrote the same problem up elsewhere.
Questions about this 483
What did FDA find at Products By 02, Inc.?
FDA listed 1 observation on this Form 483, mostly about materials. The most-cited regulation is 21 CFR 211.84 (testing and approval or rejection of components, drug product containers, and closures). The opening words of each observation are shown on this page.
Who inspected Products By 02, Inc.?
Steven A. Brettler is named on this Form 483, for the inspection of Oct 17 – Oct 23, 2023. Each investigator has a profile showing what they cite most.
When was Products By 02, Inc. inspected by FDA?
The inspection ran Oct 17 – Oct 23, 2023, and the Form 483 is dated October 23, 2023.
How do I get the full Form 483 for Products By 02, 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.