Syntho Pharmaceuticals Inc.
Form 483 issued August 26, 2016 · Farmingdale, New York
- Inspection
- Aug 10 – Aug 26, 2016
- Investigators
- Alice S. Tsao· Mindy M. Chou
- Observations
- 24
- Pages
- 18
- FEI number
- 3003407422
In short: On August 26, 2016, FDA issued a Form 483 with 24 observations to Syntho Pharmaceuticals Inc. in Farmingdale, New York (FEI 3003407422) after an inspection that ran Aug 10 – Aug 26, 2016. The investigators were Alice S. Tsao and Mindy M. Chou. Most observations concern laboratory controls and production; 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(a) (2×) · 211.160(b)(4) (2×)
What FDA observed
Preview: the opening words of each observation- 01
Drug products failing to meet established…
- 02
The quality control unit lacks authority to review production records to assure that no errors have…
- 03
The responsibilities and procedures applicable to the quality control unit are not in…
- 04
Employees are not given training in written procedures required by current…
This inspection in context
Alice S. Tsao
16 documents · 2011–2023
Cites 211.67 (equipment cleaning and maintenance) 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(a)
See how FDA wrote the same problem up elsewhere.
Questions about this 483
What did FDA find at Syntho Pharmaceuticals Inc.?
FDA listed 24 observations on this Form 483, mostly about laboratory controls, production and quality system. 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.?
Alice S. Tsao and Mindy M. Chou are named on this Form 483, for the inspection of Aug 10 – Aug 26, 2016. Each investigator has a profile showing what they cite most.
When was Syntho Pharmaceuticals Inc. inspected by FDA?
The inspection ran Aug 10 – Aug 26, 2016, and the Form 483 is dated August 26, 2016.
How do I get the full Form 483 for Syntho Pharmaceuticals Inc.?
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