Syntho Pharmaceuticals Inc.
FDA inspection history in Farmingdale, New York, 2003 to 2024
- 3
- Form 483s
- 2
- Warning letters
Every document, by year
- Form 483
- Warning letter
2003: one warning letter; 2015: one warning letter; 2016: one Form 483; 2019: one Form 483; 2024: one Form 483.
The story so far
Built from the dates and citations on the documents themselves.
- 2003One warning letter, at Farmingdale, New York.
- 2015–16One warning letter and one Form 483, at Farmingdale, New York.
- 2016The longest 483 on file: 24 observations over 18 pages at Farmingdale, New York.
- 2019One Form 483, at Farmingdale, New York.
- 2024One Form 483, at Farmingdale, New York.
Cited most
Across all Syntho Pharmaceuticals observations on file
- 21 CFR 211.160General requirements12
- 21 CFR 211.110Sampling and testing of in-process materials and drug products4
- 21 CFR 211.67Equipment cleaning and maintenance4
- 21 CFR 211.80General requirements4
- 21 CFR 211.165Testing and release for distribution3
The complete Syntho Pharmaceuticals file.
All 5 documents as original PDFs, in one order. For supplier audits, diligence and inspection prep.
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Sites
Farmingdale, New York
Three Form 483s and two warning letters · 2003 to 2024 · 51 observations
Latest: Form 483, Mar 1, 2024 →
Documents
5 on file, newest first| Date | Document | Location | Observations | Price |
|---|---|---|---|---|
| 2024-03-01 | 483 Form 483 | Farmingdale, New York | 14 | $99 |
| 2019-09-03 | 483 Form 483 | Farmingdale, New York | 13 | $99 |
| 2016-08-26 | 483 Form 483 | Farmingdale, New York | 24 | $99 |
| 2015-06-22 | Warning letter Warning letter | Farmingdale, New York | — | $99 |
| 2003-03-14 | Warning letter Warning letter | Farmingdale, New York | — | $99 |
Investigators on these documents
Alice S. Tsao (1)J'maica J. Hunter (1)Jose O. Hernandez (1)Mindy M. Chou (1)Tanya R. Syffrard (1)
FEI number 3003407422 · most recent document Mar 1, 2024
About Syntho Pharmaceuticals Inc.
How many FDA Form 483s has Syntho Pharmaceuticals Inc. received?
FDA Intel has 3 Form 483s on file for Syntho Pharmaceuticals Inc.; the most recent is dated Mar 1, 2024.
When was Syntho Pharmaceuticals Inc. last inspected by FDA?
The most recent FDA inspection document on file for Syntho Pharmaceuticals Inc. is a Form 483 dated Mar 1, 2024, for the site in Farmingdale, New York.
What did FDA cite at Syntho Pharmaceuticals Inc.?
The regulations cited most in the observations on file for Syntho Pharmaceuticals Inc. are 21 CFR 211.160 (General requirements), 12 times; 21 CFR 211.110 (Sampling and testing of in-process materials and drug products), 4 times; 21 CFR 211.67 (Equipment cleaning and maintenance), 4 times.
Has Syntho Pharmaceuticals Inc. received an FDA warning letter?
Yes. FDA Intel has 2 FDA warning letters on file for Syntho Pharmaceuticals Inc.; the most recent is dated Jun 22, 2015.