New SPS Crossfolds, LLC (d/b/a Radienz Living)
Form 483 issued January 11, 2024 · Commack, New York
- Inspection
- Jan 9 – Jan 11, 2024
- Investigators
- Syeda N. Mahazabin· Victoria Spivak
- Observations
- 6
- Pages
- 5
- FEI number
- 3000285187
In short: On January 11, 2024, FDA issued a Form 483 with 6 observations to New SPS Crossfolds, LLC (d/b/a Radienz Living) in Commack, New York (FEI 3000285187) after an inspection that ran Jan 9 – Jan 11, 2024. The investigators were Syeda N. Mahazabin and Victoria Spivak. Most observations concern facilities & equipment and production.
At a glance
Facilities & equipment and production account for 5 of 6 observations.
What FDA observed
Preview: the opening words of each observation- 01
Control procedures are not established which monitor the output and validate the performance of those manufacturing…
- 02
Appropriate controls are not exercised over computers or related systems to assure that changes in taster…
- 03
Equipment used in the manufacture, processing, packing or holding of drug products is not of appropriate…
- 04
Written procedures are not established and followed for the cleaning and maintenance of equipment, including utensils…
This inspection in context
Syeda N. Mahazabin
19 documents · 2006–2026
Cites 211.67 (equipment cleaning and maintenance) more than any other section. Most of their documents are for sites in New York.
The firmNew SPS Crossfolds, LLC (d/b/a Radienz Living) history
The site's inspection history, in date order.
Similar 483sOther sites cited under 211.110(a)
See how FDA wrote the same problem up elsewhere.
Questions about this 483
What did FDA find at New SPS Crossfolds, LLC (d/b/a Radienz Living)?
FDA listed 6 observations on this Form 483, mostly about facilities & equipment, production and materials. The opening words of each observation are shown on this page.
Who inspected New SPS Crossfolds, LLC (d/b/a Radienz Living)?
Syeda N. Mahazabin and Victoria Spivak are named on this Form 483, for the inspection of Jan 9 – Jan 11, 2024. Each investigator has a profile showing what they cite most.
When was New SPS Crossfolds, LLC (d/b/a Radienz Living) inspected by FDA?
The inspection ran Jan 9 – Jan 11, 2024, and the Form 483 is dated January 11, 2024.
How do I get the full Form 483 for New SPS Crossfolds, LLC (d/b/a Radienz Living)?
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.