Saptalis Pharmaceuticals, LLC
FDA inspection history in Hauppauge, New York, 2018 to 2026
- 3
- Form 483s
Every document, by year
- Form 483
2018: one Form 483; 2023: one Form 483; 2026: one Form 483.
The story so far
Built from the dates and citations on the documents themselves.
- 2018One Form 483, at Hauppauge, New York.
- 2023One Form 483, at Hauppauge, New York.
- 2023The longest 483 on file: 4 observations over 4 pages at Hauppauge, New York.
- 2026One Form 483, at Hauppauge, New York.
Cited most
Across all Saptalis Pharmaceuticals observations on file
- 21 CFR 211.80General requirements2
- 21 CFR 211.110Sampling and testing of in-process materials and drug products1
- 21 CFR 211.165Testing and release for distribution1
- 21 CFR 211.63Equipment design, size, and location1
- 21 CFR 211.67Equipment cleaning and maintenance1
The complete Saptalis Pharmaceuticals file.
All 3 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
Hauppauge, New York
Three Form 483s · 2018 to 2026 · 8 observations
Latest: Form 483, Mar 6, 2026 →
Documents
3 on file, newest first| Date | Document | Location | Observations | Price |
|---|---|---|---|---|
| 2026-03-06 | 483 Form 483 | Hauppauge, New York | 1 | $99 |
| 2023-03-17 | 483 Form 483 | Hauppauge, New York | 4 | $99 |
| 2018-10-30 | 483 Form 483 | Hauppauge, New York | 3 | $99 |
Investigators on these documents
Amatul H. Marium (1)Bijoy Panicker (1)Josh Renzo N. Ramilo (1)Sony Mathews (1)
FEI number 3012152381 · most recent document Mar 6, 2026
About Saptalis Pharmaceuticals, LLC
How many FDA Form 483s has Saptalis Pharmaceuticals, LLC received?
FDA Intel has 3 Form 483s on file for Saptalis Pharmaceuticals, LLC; the most recent is dated Mar 6, 2026.
When was Saptalis Pharmaceuticals, LLC last inspected by FDA?
The most recent FDA inspection document on file for Saptalis Pharmaceuticals, LLC is a Form 483 dated Mar 6, 2026, for the site in Hauppauge, New York.
What did FDA cite at Saptalis Pharmaceuticals, LLC?
The regulations cited most in the observations on file for Saptalis Pharmaceuticals, LLC are 21 CFR 211.80 (General requirements), 2 times; 21 CFR 211.110 (Sampling and testing of in-process materials and drug products), 1 time; 21 CFR 211.165 (Testing and release for distribution), 1 time.