Syntho Pharmaceuticals Inc.
Form 483 issued March 1, 2024 · Farmingdale, New York
- Inspection
- Jan 4 – Mar 1, 2024
- Investigators
- J'maica J. Hunter· Tanya R. Syffrard
- Observations
- 14
- Pages
- 16
- FEI number
- 3003407422
In short: On March 1, 2024, FDA issued a Form 483 with 14 observations to Syntho Pharmaceuticals Inc. in Farmingdale, New York (FEI 3003407422) after an inspection that ran Jan 4 – Mar 1, 2024. The investigators were J'maica J. Hunter and Tanya R. Syffrard. Most observations concern laboratory controls and quality system; the most-cited regulation is 21 CFR 211.160 (general requirements).
At a glance
Observations span 4 systems, led by laboratory controls.
Most cited: 21 CFR 211.160 (3×)
What FDA observed
Preview: the opening words of each observationDashed: section inferred by FDA Intel and checked against the regulation text
- 01
There is no quality…
- 02
The accuracy, sensitivity, specificity and reproducibility of test methods have not…
- 03
The written stability testing…
- 04
Laboratory controls do not include the establishment of scientifically sound and appropriate specifications and test procedures…
This inspection in context
J'maica J. Hunter
5 documents · 2024–2026
Cites 211.110 (sampling and testing of in-process materials and drug products) more than any other section. Most of their documents are for sites in Georgia.
The firmSyntho Pharmaceuticals Inc. history
All 5 documents on file for this site, in date order, with what was cited at each inspection.
Similar 483sOther sites cited under 211.160
See how FDA wrote the same problem up elsewhere.
Questions about this 483
What did FDA find at Syntho Pharmaceuticals Inc.?
FDA listed 14 observations on this Form 483, mostly about laboratory controls, quality system and facilities & equipment. The most-cited regulation is 21 CFR 211.160 (general requirements). The opening words of each observation are shown on this page.
Who inspected Syntho Pharmaceuticals Inc.?
J'maica J. Hunter and Tanya R. Syffrard are named on this Form 483, for the inspection of Jan 4 – Mar 1, 2024. Each investigator has a profile showing what they cite most.
When was Syntho Pharmaceuticals Inc. inspected by FDA?
The inspection ran Jan 4 – Mar 1, 2024, and the Form 483 is dated March 1, 2024.
How do I get the full Form 483 for Syntho Pharmaceuticals Inc.?
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.