MeriCal LLC
Form 483 issued April 30, 2025 · Orange, California
- Inspection
- Apr 21 – Apr 30, 2025
- Investigator
- Tiara M. Brown
- Observations
- 2
- Pages
- 3
- FEI number
- 3001574462
In short: On April 30, 2025, FDA issued a Form 483 with 2 observations to MeriCal LLC in Orange, California (FEI 3001574462) after an inspection that ran Apr 21 – Apr 30, 2025. The investigator was Tiara M. Brown. Most observations concern materials and laboratory controls; the most-cited regulation is 21 CFR 211.84 (testing and approval or rejection of components, drug product containers, and closures).
At a glance
Materials and laboratory controls account for 2 of 2 observations.
Most cited: 21 CFR 211.84(b) (1×) · 211.194(a)(5) (1×)
What FDA observed
Preview: the opening words of each observation- 01
Representative samples are not taken of each shipment of each lot of drug product containers…
- 02
Laboratory records do not include a record of all calculations performed in…
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 firmMeriCal LLC history
The site's inspection history, in date order.
Similar 483sOther sites cited under 211.84(b)
See how FDA wrote the same problem up elsewhere.
Questions about this 483
What did FDA find at MeriCal LLC?
FDA listed 2 observations on this Form 483, mostly about materials and laboratory controls. 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 MeriCal LLC?
Tiara M. Brown is named on this Form 483, for the inspection of Apr 21 – Apr 30, 2025. Each investigator has a profile showing what they cite most.
When was MeriCal LLC inspected by FDA?
The inspection ran Apr 21 – Apr 30, 2025, and the Form 483 is dated April 30, 2025.
How do I get the full Form 483 for MeriCal 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.