Saptalis Pharmaceuticals, LLC
Form 483 issued October 30, 2018 · Hauppauge, New York
- Inspection
- Oct 15 – Oct 30, 2018
- Investigator
- Sony Mathews
- Observations
- 3
- Pages
- 2
- FEI number
- 3012152381
In short: On October 30, 2018, FDA issued a Form 483 with 3 observations to Saptalis Pharmaceuticals, LLC in Hauppauge, New York (FEI 3012152381) after an inspection that ran Oct 15 – Oct 30, 2018. The investigator was Sony Mathews. Most observations concern facilities & equipment and materials.
At a glance
Facilities & equipment and materials account for 2 of 3 observations.
What FDA observed
Preview: the opening words of each observationDashed: section inferred by FDA Intel and checked against the regulation text
- 01
Written procedures are not established for the cleaning and maintenance of equipment, including utensils, used in…
- 02
Procedures describing the warehousing of drug…
- 03
The accuracy, sensitivity, and reproducibility of test method…
This inspection in context
Sony Mathews
22 documents · 2010–2022
Cites 211.67 (equipment cleaning and maintenance) more than any other section. Most of their documents are for sites in New York.
The firmSaptalis Pharmaceuticals, LLC history
All 3 documents on file for this site, in date order, with what was cited at each inspection.
Similar 483sOther sites cited under 211.67
See how FDA wrote the same problem up elsewhere.
Questions about this 483
What did FDA find at Saptalis Pharmaceuticals, LLC?
FDA listed 3 observations on this Form 483, mostly about facilities & equipment, materials and laboratory controls. The opening words of each observation are shown on this page.
Who inspected Saptalis Pharmaceuticals, LLC?
Sony Mathews is named on this Form 483, for the inspection of Oct 15 – Oct 30, 2018. Each investigator has a profile showing what they cite most.
When was Saptalis Pharmaceuticals, LLC inspected by FDA?
The inspection ran Oct 15 – Oct 30, 2018, and the Form 483 is dated October 30, 2018.
How do I get the full Form 483 for Saptalis Pharmaceuticals, 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.