Syntec Pharma Corp
Form 483 issued October 28, 2020 · Farmingdale, New York
- Inspection
- Oct 7 – Oct 28, 2020
- Investigators
- Jay T. Wong· Vivin George
- Observations
- 9
- Pages
- 5
- FEI number
- 3010057717
In short: On October 28, 2020, FDA issued a Form 483 with 9 observations to Syntec Pharma Corp in Farmingdale, New York (FEI 3010057717) after an inspection that ran Oct 7 – Oct 28, 2020. The investigators were Jay T. Wong and Vivin George. Most observations concern facilities & equipment and materials; the most-cited regulation is 21 CFR 211.42 (design and construction features).
At a glance
Facilities & equipment and materials account for 6 of 9 observations.
Most cited: 21 CFR 211.42 (2×)
What FDA observed
Preview: the opening words of each observationDashed: section inferred by FDA Intel and checked against the regulation text
- 01
Failure to handle, store, or repackage P-lactam antibiotics and cytotoxic chemotherapy drug product(s) separate from other…
- 02
Written procedures are not validated for the cleaning and maintenance of equipment, including utensils, used in…
- 03
There is no quality…
- 04
API and/or raw materials, components, containers and closures do not have an orderly placement in order…
This inspection in context
Jay T. Wong
5 documents · 2019–2020
Cites 211.42 (design and construction features) more than any other section. Most of their documents are for sites in New York.
The firmSyntec Pharma Corp history
All 2 documents on file for this site, in date order, with what was cited at each inspection.
Similar 483sOther sites cited under 211.42
See how FDA wrote the same problem up elsewhere.
Questions about this 483
What did FDA find at Syntec Pharma Corp?
FDA listed 9 observations on this Form 483, mostly about facilities & equipment, materials and quality system. The most-cited regulation is 21 CFR 211.42 (design and construction features). The opening words of each observation are shown on this page.
Who inspected Syntec Pharma Corp?
Jay T. Wong and Vivin George are named on this Form 483, for the inspection of Oct 7 – Oct 28, 2020. Each investigator has a profile showing what they cite most.
When was Syntec Pharma Corp inspected by FDA?
The inspection ran Oct 7 – Oct 28, 2020, and the Form 483 is dated October 28, 2020.
How do I get the full Form 483 for Syntec Pharma Corp?
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.