Syntho Pharmaceuticals Inc.
Form 483 issued September 3, 2019 · Farmingdale, New York
- Inspection
- Jul 17 – Sep 3, 2019
- Investigator
- Jose O. Hernandez
- Observations
- 13
- Pages
- 8
- FEI number
- 3003407422
In short: On September 3, 2019, FDA issued a Form 483 with 13 observations to Syntho Pharmaceuticals Inc. in Farmingdale, New York (FEI 3003407422) after an inspection that ran Jul 17 – Sep 3, 2019. The investigator was Jose O. Hernandez. Most observations concern laboratory controls and quality system; the most-cited regulation is 21 CFR 211.160 (general requirements).
At a glance
Laboratory controls and quality system account for 8 of 13 observations.
Most cited: 21 CFR 211.160(b)(4) (2×)
What FDA observed
Preview: the opening words of each observation- 01
The accuracy, sensitivity, specificity and reproducibility of test methods have not…
- 02
Established test procedures are…
- 03
Laboratory controls do not include the establishment of scientifically sound and appropriate test procedures designed to…
- 04
Procedures describing the calibration of instruments, apparatus, gauges and recording devices are…
This inspection in context
Jose O. Hernandez
12 documents · 2015–2020
Cites 211.160 (general requirements) more than any other section. Most of their documents are for sites in New York.
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(b)(4)
See how FDA wrote the same problem up elsewhere.
Questions about this 483
What did FDA find at Syntho Pharmaceuticals Inc.?
FDA listed 13 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.?
Jose O. Hernandez is named on this Form 483, for the inspection of Jul 17 – Sep 3, 2019. Each investigator has a profile showing what they cite most.
When was Syntho Pharmaceuticals Inc. inspected by FDA?
The inspection ran Jul 17 – Sep 3, 2019, and the Form 483 is dated September 3, 2019.
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.