Optimal Solution Labs LLC
Form 483 issued November 6, 2024 · Valencia, California
- Inspection
- Oct 29 – Nov 6, 2024
- Investigator
- Tiara M. Brown
- Observations
- 7
- Pages
- 7
- FEI number
- 3026767012
In short: On November 6, 2024, FDA issued a Form 483 with 7 observations to Optimal Solution Labs LLC in Valencia, California (FEI 3026767012) after an inspection that ran Oct 29 – Nov 6, 2024. The investigator was Tiara M. Brown. Most observations concern facilities & equipment and quality system; the most-cited regulation is 21 CFR 211.67 (equipment cleaning and maintenance).
At a glance
Observations span 4 systems, led by facilities & equipment.
What FDA observed
Preview: the opening words of each observation- 01
The responsibilities and procedures applicable to the quality control unit are not in…
- 02
Records are not kept for the maintenance, cleaning, sanitizing…
- 03
There is no written testing program designed to assess the stability…
- 04
Your firm failed to establish written procedures for production and process controls designed to assure that…
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 firmOptimal Solution Labs LLC history
The site's inspection history, in date order.
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 Optimal Solution Labs LLC?
FDA listed 7 observations on this Form 483, mostly about facilities & equipment, quality system and laboratory controls. The most-cited regulation is 21 CFR 211.67 (equipment cleaning and maintenance). The opening words of each observation are shown on this page.
Who inspected Optimal Solution Labs LLC?
Tiara M. Brown is named on this Form 483, for the inspection of Oct 29 – Nov 6, 2024. Each investigator has a profile showing what they cite most.
When was Optimal Solution Labs LLC inspected by FDA?
The inspection ran Oct 29 – Nov 6, 2024, and the Form 483 is dated November 6, 2024.
How do I get the full Form 483 for Optimal Solution Labs LLC?
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.