Prime Enterprises, LLC dba Prime Matter Labs
Form 483 issued September 1, 2023 · Miami, Florida
- Inspection
- Aug 23 – Sep 1, 2023
- Observations
- 5
- Pages
- 5
- FEI number
- 1036626
In short: On September 1, 2023, FDA issued a Form 483 with 5 observations to Prime Enterprises, LLC dba Prime Matter Labs in Miami, Florida (FEI 1036626) after an inspection that ran Aug 23 – Sep 1, 2023. Most observations concern production and laboratory controls.
At a glance
Production and laboratory controls account for 3 of 5 observations.
What FDA observed
Preview: the opening words of each observation- 01
Laboratory controls do not include the establishment of scientifically sound and appropriate specifications and standards designed…
- 02
Buildings used in the manufacturing, processing, packing and holding of a drug product are not maintained…
- 03
Your firm failed to establish written procedures for production and process controls designed to assure that…
- 04
Reprocessing was performed without the review and approval of…
This inspection in context
Questions about this 483
What did FDA find at Prime Enterprises, LLC dba Prime Matter Labs?
FDA listed 5 observations on this Form 483, mostly about production, laboratory controls and facilities & equipment. The opening words of each observation are shown on this page.
When was Prime Enterprises, LLC dba Prime Matter Labs inspected by FDA?
The inspection ran Aug 23 – Sep 1, 2023, and the Form 483 is dated September 1, 2023.
How do I get the full Form 483 for Prime Enterprises, LLC dba Prime Matter Labs?
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.