Orange Lab
FDA inspection history in Anaheim, California, 2023 to 2024
- 2
- Form 483s
Every document, by year
- Form 483
2023: one Form 483; 2024: one Form 483.
The story so far
Built from the dates and citations on the documents themselves.
- 2023–24Two Form 483s, at Anaheim, California.
- 2023The longest 483 on file: 9 observations over 7 pages at Anaheim, California.
Cited most
Across all Orange Lab observations on file
- 21 CFR 211.100Written procedures; deviations2
- 21 CFR 211.22Responsibilities of quality control unit2
- 21 CFR 211.67Equipment cleaning and maintenance2
- 21 CFR 211.68Automatic, mechanical, and electronic equipment2
- 21 CFR 211.84(d)(1)Testing and approval or rejection of components, drug product containers, and closures2
The complete Orange Lab 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
Anaheim, California
Two Form 483s · 2023 to 2024 · 17 observations
Latest: Form 483, Jul 19, 2024 →
Documents
2 on file, newest first| Date | Document | Location | Observations | Price |
|---|---|---|---|---|
| 2024-07-19 | 483 Form 483 | Anaheim, California | 8 | $99 |
| 2023-09-21 | 483 Form 483 | Anaheim, California | 9 | $99 |
Investigators on these documents
FEI number 3011893701 · most recent document Jul 19, 2024
About Orange Lab
How many FDA Form 483s has Orange Lab received?
FDA Intel has 2 Form 483s on file for Orange Lab; the most recent is dated Jul 19, 2024.
When was Orange Lab last inspected by FDA?
The most recent FDA inspection document on file for Orange Lab is a Form 483 dated Jul 19, 2024, for the site in Anaheim, California.
What did FDA cite at Orange Lab?
The regulations cited most in the observations on file for Orange Lab are 21 CFR 211.100 (Written procedures; deviations), 2 times; 21 CFR 211.22 (Responsibilities of quality control unit), 2 times; 21 CFR 211.67 (Equipment cleaning and maintenance), 2 times.