Natural Technology LLC dba NaturTech LLC
Form 483 issued March 1, 2024 · Terrell, Texas
- Inspection
- Feb 26 – Mar 1, 2024
- Investigator
- Damaris Y. Hernandez
- Observations
- 9
- Pages
- 11
- FEI number
- 1643811
In short: On March 1, 2024, FDA issued a Form 483 with 9 observations to Natural Technology LLC dba NaturTech LLC in Terrell, Texas (FEI 1643811) after an inspection that ran Feb 26 – Mar 1, 2024. The investigator was Damaris Y. Hernandez. Most observations concern facilities & equipment and laboratory controls.
At a glance
Facilities & equipment and laboratory controls account for 6 of 9 observations.
What FDA observed
Preview: the opening words of each observation- 01
Drug product component testing is deficient in that at least one specific test to verify the…
- 02
Each batch of drug product required to be free of objectionable microorganisms is not tested…
- 03
Equipment used in the manufacture, processing, packing or holding of drug products is not of appropriate…
- 04
The responsibilities and procedures applicable to the quality control unit…
This inspection in context
Damaris Y. Hernandez
17 documents · 2022–2026
Cites 211.22 (responsibilities of quality control unit) more than any other section. Most of their documents are for sites in Florida.
The firmNatural Technology LLC dba NaturTech LLC history
The site's inspection history, in date order.
Similar 483sOther sites cited under 211.84(d)(1)
See how FDA wrote the same problem up elsewhere.
Questions about this 483
What did FDA find at Natural Technology LLC dba NaturTech LLC?
FDA listed 9 observations on this Form 483, mostly about facilities & equipment, laboratory controls and quality system. The opening words of each observation are shown on this page.
Who inspected Natural Technology LLC dba NaturTech LLC?
Damaris Y. Hernandez is named on this Form 483, for the inspection of Feb 26 – Mar 1, 2024. Each investigator has a profile showing what they cite most.
When was Natural Technology LLC dba NaturTech LLC inspected by FDA?
The inspection ran Feb 26 – Mar 1, 2024, and the Form 483 is dated March 1, 2024.
How do I get the full Form 483 for Natural Technology LLC dba NaturTech 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.