Prime Enterprises, LLC dba Prime Matter Labs
FDA inspection history across 2 sites, 2009 to 2023
- 1
- Form 483
- 1
- Warning letter
Every document, by year
- Form 483
- Warning letter
2009: one warning letter; 2023: one Form 483.
The story so far
Built from the dates and citations on the documents themselves.
- 2009One warning letter, at Miami Lakes, Florida.
- 2023One Form 483, at Miami, Florida.
Cited most
Across all Prime Enterprises, LLC dba Prime Matter Labs observations on file
- 21 CFR 211.100(a)Written procedures; deviations1
- 21 CFR 211.115(b)Reprocessing1
- 21 CFR 211.160(b)General requirements1
- 21 CFR 211.192Production record review1
- 21 CFR 211.58Maintenance1
The complete Prime Enterprises, LLC dba Prime Matter Labs file.
All 2 documents as original PDFs, in one order. For supplier audits, diligence and inspection prep.
The price of the documents, added to your cart together
Sites
Miami, Florida
One Form 483 · 2023 · 5 observations
Latest: Form 483, Sep 1, 2023 →Miami Lakes, Florida
One warning letter · 2009
Latest: Warning letter, Jan 29, 2009 →
Documents
2 on file, newest first| Date | Document | Location | Observations | Price |
|---|---|---|---|---|
| 2023-09-01 | 483 Form 483 | Miami, Florida | 5 | $99 |
| 2009-01-29 | Warning letter Warning letter | Miami Lakes, Florida | — | $99 |
FEI number 1036626 · most recent document Sep 1, 2023
About Prime Enterprises, LLC dba Prime Matter Labs
How many FDA Form 483s has Prime Enterprises, LLC dba Prime Matter Labs received?
FDA Intel has 1 Form 483 on file for Prime Enterprises, LLC dba Prime Matter Labs; the most recent is dated Sep 1, 2023.
When was Prime Enterprises, LLC dba Prime Matter Labs last inspected by FDA?
The most recent FDA inspection document on file for Prime Enterprises, LLC dba Prime Matter Labs is a Form 483 dated Sep 1, 2023, for the site in Miami, Florida.
What did FDA cite at Prime Enterprises, LLC dba Prime Matter Labs?
The regulations cited most in the observations on file for Prime Enterprises, LLC dba Prime Matter Labs are 21 CFR 211.100(a) (Written procedures; deviations), 1 time; 21 CFR 211.115(b) (Reprocessing), 1 time; 21 CFR 211.160(b) (General requirements), 1 time.
Has Prime Enterprises, LLC dba Prime Matter Labs received an FDA warning letter?
Yes. FDA Intel has 1 FDA warning letter on file for Prime Enterprises, LLC dba Prime Matter Labs; the most recent is dated Jan 29, 2009.