Orange Lab
Form 483 issued September 21, 2023 · Anaheim, California
- Inspection
- Sep 18 – Sep 21, 2023
- Investigators
- Andrew Le· Darren S. Brown
- Observations
- 9
- Pages
- 7
- FEI number
- 3011893701
In short: On September 21, 2023, FDA issued a Form 483 with 9 observations to Orange Lab in Anaheim, California (FEI 3011893701) after an inspection that ran Sep 18 – Sep 21, 2023. The investigators were Andrew Le and Darren S. Brown. Most observations concern materials and facilities & equipment; the most-cited regulation is 21 CFR 211.84 (testing and approval or rejection of components, drug product containers, and closures).
At a glance
Observations span 4 systems, led by materials.
What FDA observed
Preview: the opening words of each observation- 0121 CFR 11
Electronic records are used, but they do not meet retention, audit trail and signature to record…
- 02
The responsibilities and procedures applicable to the quality control unit…
- 03
The identity of each component of a drug product is not verified by conducting at least…
- 04
Each component is not tested for conformity with all appropriate written specifications for…
This inspection in context
Andrew Le
10 documents · 2022–2025
Cites 211.84 (testing and approval or rejection of components, drug product containers, and closures) more than any other section. Most of their documents are for sites in California.
The firmOrange Lab history
All 2 documents on file for this site, in date order, with what was cited at each inspection.
Similar 483sOther sites cited under 211.22(d)
See how FDA wrote the same problem up elsewhere.
Questions about this 483
What did FDA find at Orange Lab?
FDA listed 9 observations on this Form 483, mostly about materials, facilities & equipment and quality system. 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 Orange Lab?
Andrew Le and Darren S. Brown are named on this Form 483, for the inspection of Sep 18 – Sep 21, 2023. Each investigator has a profile showing what they cite most.
When was Orange Lab inspected by FDA?
The inspection ran Sep 18 – Sep 21, 2023, and the Form 483 is dated September 21, 2023.
How do I get the full Form 483 for Orange Lab?
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.