Dr. Brite LLC
Form 483 issued April 5, 2024 · Fullerton, California
- Inspection
- Apr 2 – Apr 5, 2024
- Investigator
- Andrew Le
- Observations
- 6
- Pages
- 6
- FEI number
- 3016665985
In short: On April 5, 2024, FDA issued a Form 483 with 6 observations to Dr. Brite LLC in Fullerton, California (FEI 3016665985) after an inspection that ran Apr 2 – Apr 5, 2024. The investigator was Andrew Le. Most observations concern production and laboratory controls.
At a glance
Production and laboratory controls account for 4 of 6 observations.
What FDA observed
Preview: the opening words of each observation- 01
The responsibilities and procedures applicable to the quality control unit…
- 02
Batch production and control records do not include complete information relating to the production and…
- 03
The identity of each component of a drug product is not verified by conducting at least…
- 04
Testing and release of drug product for distribution do not include appropriate laboratory determination of satisfactory…
This inspection in context
Andrew Le
10 documents · 2022–2025
Cites 211.84 (testing and approval or rejection of components, drug product containers, and closures) more than any other section. Most of their documents are for sites in California.
The firmDr. Brite LLC history
All 2 documents on file for this site, in date order, with what was cited at each inspection.
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 Dr. Brite LLC?
FDA listed 6 observations on this Form 483, mostly about production, laboratory controls and quality system. The opening words of each observation are shown on this page.
Who inspected Dr. Brite LLC?
Andrew Le is named on this Form 483, for the inspection of Apr 2 – Apr 5, 2024. Each investigator has a profile showing what they cite most.
When was Dr. Brite LLC inspected by FDA?
The inspection ran Apr 2 – Apr 5, 2024, and the Form 483 is dated April 5, 2024.
How do I get the full Form 483 for Dr. Brite 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.