Products by O2, Inc.
Form 483 issued October 23, 2023 · Fort Lauderdale, Florida
- Inspection
- Oct 17 – Oct 23, 2023
- Investigator
- Steven A. Brettler
- Observations
- 11
- Pages
- 10
- FEI number
- 3005835723
In short: On October 23, 2023, FDA issued a Form 483 with 11 observations to Products by O2, Inc. in Fort Lauderdale, Florida (FEI 3005835723) after an inspection that ran Oct 17 – Oct 23, 2023. The investigator was Steven A. Brettler. Most observations concern facilities & equipment and production; the most-cited regulation is 21 CFR 211.100 (written procedures; deviations).
At a glance
Observations span 4 systems, led by facilities & equipment.
Most cited: 21 CFR 211.100(a) (2×)
What FDA observed
Preview: the opening words of each observation- 01
Specific identification tests are not conducted on components that have been accepted based on the…
- 02
The responsibilities and procedures applicable to the quality control unit are not in…
- 03
Written procedures are not established and followed for the cleaning and maintenance of equipment, including utensils…
- 04
Equipment used in the manufacture, processing, packing or holding of drug products is not of appropriate…
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 O2, Inc. history
The site's inspection history, in date order.
Similar 483sOther sites cited under 211.100(a)
See how FDA wrote the same problem up elsewhere.
Questions about this 483
What did FDA find at Products by O2, Inc.?
FDA listed 11 observations on this Form 483, mostly about facilities & equipment, production and laboratory controls. The most-cited regulation is 21 CFR 211.100 (written procedures; deviations). The opening words of each observation are shown on this page.
Who inspected Products by O2, 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 O2, 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 O2, 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.