Orange Lab
Form 483 issued July 19, 2024 · Anaheim, California
- Inspection
- Jul 8 – Jul 19, 2024
- Observations
- 8
- Pages
- 13
- FEI number
- 3011893701
In short: On July 19, 2024, FDA issued a Form 483 with 8 observations to Orange Lab in Anaheim, California (FEI 3011893701) after an inspection that ran Jul 8 – Jul 19, 2024. Most observations concern quality system and facilities & equipment; the most-cited regulation is 21 CFR 211.68 (automatic, mechanical, and electronic equipment).
At a glance
Quality system and facilities & equipment account for 6 of 8 observations.
Most cited: 21 CFR 211.68 (2×)
What FDA observed
Preview: the opening words of each observationDashed: section inferred by FDA Intel and checked against the regulation text
- 01
The responsibilities and procedures applicable to the quality control unit are not in…
- 02
Written procedures are not established and followed for the cleaning and maintenance of equipment, including utensils…
- 03
Written procedures are not drafted, reviewed, and approved by the appropriate organizational units and reviewed and…
- 04
Appropriate controls are not exercised over computers or related systems to assure that changes in master…
This inspection in context
Questions about this 483
What did FDA find at Orange Lab?
FDA listed 8 observations on this Form 483, mostly about quality system, 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.
When was Orange Lab inspected by FDA?
The inspection ran Jul 8 – Jul 19, 2024, and the Form 483 is dated July 19, 2024.
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.