Saptalis Pharmaceuticals, LLC
Form 483 issued March 17, 2023 · Hauppauge, New York
- Inspection
- Mar 9 – Mar 17, 2023
- Investigators
- Amatul H. Marium· Bijoy Panicker· Josh Renzo N. Ramilo
- Observations
- 4
- Pages
- 4
- FEI number
- 3012152381
In short: On March 17, 2023, FDA issued a Form 483 with 4 observations to Saptalis Pharmaceuticals, LLC in Hauppauge, New York (FEI 3012152381) after an inspection that ran Mar 9 – Mar 17, 2023. The investigators were Amatul H. Marium, Bijoy Panicker and Josh Renzo N. Ramilo. Most observations concern materials and facilities & equipment.
At a glance
Materials and facilities & equipment account for 3 of 4 observations.
What FDA observed
Preview: the opening words of each observationDashed: section inferred by FDA Intel and checked against the regulation text
- 01
Appropriate controls are not exercised over computers or related systems to assure that changes in master…
- 02
Written procedures are lacking which describe in sufficient detail the sampling, testing, approval…
- 03
In-process materials are not tested for identity, strength, quality and purity and approved or rejected by…
- 04
Rejected drug product containers are not controlled under a quarantine system designed to prevent their use…
This inspection in context
Amatul H. Marium
8 documents · 2022–2026
Cites 211.68 (automatic, mechanical, and electronic equipment) 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 211.68
See how FDA wrote the same problem up elsewhere.
Questions about this 483
What did FDA find at Saptalis Pharmaceuticals, LLC?
FDA listed 4 observations on this Form 483, mostly about materials, facilities & equipment and production. The opening words of each observation are shown on this page.
Who inspected Saptalis Pharmaceuticals, LLC?
Amatul H. Marium, Bijoy Panicker and Josh Renzo N. Ramilo are named on this Form 483, for the inspection of Mar 9 – Mar 17, 2023. Each investigator has a profile showing what they cite most.
When was Saptalis Pharmaceuticals, LLC inspected by FDA?
The inspection ran Mar 9 – Mar 17, 2023, and the Form 483 is dated March 17, 2023.
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.