Prime Matter Labs West
Form 483 issued August 25, 2022 · Torrance, California
- Inspection
- Aug 22 – Aug 25, 2022
- Investigator
- Khoa Nathan V. Tran
- Observations
- 3
- Pages
- 3
- FEI number
- 3021784212
In short: On August 25, 2022, FDA issued a Form 483 with 3 observations to Prime Matter Labs West in Torrance, California (FEI 3021784212) after an inspection that ran Aug 22 – Aug 25, 2022. The investigator was Khoa Nathan V. Tran. Most observations concern quality system and facilities & equipment.
At a glance
Quality system and facilities & equipment account for 2 of 3 observations.
What FDA observed
Preview: the opening words of each observation- 01
There is a failure to thoroughly review the failure of a batch or any of its…
- 02
Routine calibration of electronic equipment is not performed according to a written program designed…
- 03
Establishment of the reliability of the component supplier's report of analyses is deficient in that the…
This inspection in context
Khoa Nathan V. Tran
21 documents · 2021–2026
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 firmPrime Matter Labs West history
The site's inspection history, in date order.
Similar 483sOther sites cited under 211.192
See how FDA wrote the same problem up elsewhere.
Questions about this 483
What did FDA find at Prime Matter Labs West?
FDA listed 3 observations on this Form 483, mostly about quality system, facilities & equipment and materials. The opening words of each observation are shown on this page.
Who inspected Prime Matter Labs West?
Khoa Nathan V. Tran is named on this Form 483, for the inspection of Aug 22 – Aug 25, 2022. Each investigator has a profile showing what they cite most.
When was Prime Matter Labs West inspected by FDA?
The inspection ran Aug 22 – Aug 25, 2022, and the Form 483 is dated August 25, 2022.
How do I get the full Form 483 for Prime Matter Labs West?
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.