Michelson Laboratories Inc
Form 483 issued September 26, 2023 · Commerce, California
- Inspection
- Sep 20 – Sep 26, 2023
- Investigator
- Tiara M. Brown
- Observations
- 1
- Pages
- 3
- FEI number
- 2023045
In short: On September 26, 2023, FDA issued a Form 483 with 1 observation to Michelson Laboratories Inc in Commerce, California (FEI 2023045) after an inspection that ran Sep 20 – Sep 26, 2023. The investigator was Tiara M. Brown. Most observations concern facilities & equipment; the most-cited regulation is 21 CFR 211.68 (automatic, mechanical, and electronic equipment).
At a glance
1 of 1 observations on this 483 concern facilities & equipment.
Most cited: 21 CFR 211.68(b) (1×)
What FDA observed
Preview: the opening words of each observation- 01
Appropriate controls are not exercised over computers or related systems to assure that changes in master…
This inspection in context
Tiara M. Brown
6 documents · 2022–2025
Cites 211.100(a) (written procedures; deviations) more than any other section. Most of their documents are for sites in California.
The firmMichelson Laboratories Inc history
The site's inspection history, in date order.
Similar 483sOther sites cited under 211.68(b)
See how FDA wrote the same problem up elsewhere.
Questions about this 483
What did FDA find at Michelson Laboratories Inc?
FDA listed 1 observation on this Form 483, mostly about facilities & equipment. 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.
Who inspected Michelson Laboratories Inc?
Tiara M. Brown is named on this Form 483, for the inspection of Sep 20 – Sep 26, 2023. Each investigator has a profile showing what they cite most.
When was Michelson Laboratories Inc inspected by FDA?
The inspection ran Sep 20 – Sep 26, 2023, and the Form 483 is dated September 26, 2023.
How do I get the full Form 483 for Michelson Laboratories 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.