Drug factory · FDA FEI 3006346108

Novast Laboratories Ltd.

1 Guangxing Road, Free Trade Zone, NETDA, Nantong, China

China: 1

Problems found, fixed voluntarily at FDA's last inspection, Jul 14, 2023.

Voluntary Action Indicated: inspectors found problems, but not serious enough for FDA to take action. The company is expected to fix them.

5 drug inspections on record since 2013: 4 with no problems, 1 with problems fixed voluntarily, 0 with FDA action.

What it does, for whom

DrugRoleForNDC
AcetazolamideMakes it, tests it, packages it and labels it Ingenus Pharmaceuticals, LLC 50742-233
ClonidineMakes it, tests it, packages it and labels it Ingenus Pharmaceuticals, LLC 50742-247
Desogestrel and Ethinyl EstradiolMakes it, tests it, packages it and labels it Dr. Reddy's Laboratories Inc., Mayne Pharma Inc., Northstar Rx LLC. 75907-091, 51862-514, 51862-890 +2
DiltiazemMakes it, tests it, packages it and labels it Ingenus Pharmaceuticals, LLC 50742-248, 50742-249, 50742-250 +5
Estradiol and NorethindroneMakes it, tests it and packages it Ingenus Pharmaceuticals, LLC 50742-657, 50742-658
Estrogens, ConjugatedMakes it, tests it and packages it Ingenus Pharmaceuticals, LLC 50742-387, 50742-388, 50742-389 +2
Ethinyl Estradiol and EthynodiolMakes it, tests it, packages it and labels it Dr. Reddy's Laboratories Inc., Mayne Pharma Inc. 75907-087, 51862-894
Ethinyl Estradiol and LevonorgestrelMakes it, tests it, packages it and labels it Acella Pharmaceuticals, LLC, Avion Pharmaceuticals, LLC, Dr. Reddy's Laboratories Inc., Ingenus Pharmaceuticals, LLC, Northstar Rx LLC. 42192-623, 75854-602, 55741-005 +4
Ethinyl Estradiol and NorethindroneMakes it, tests it, packages it and labels it Dr. Reddy's Laboratories Inc., Mayne Pharma Inc., Northstar Rx LLC. 75907-081, 75907-082, 75907-083 +18
Ethinyl Estradiol and NorgestimateMakes it, tests it, packages it and labels it Mayne Pharma Inc., Northstar Rx LLC. 51862-645, 51862-646, 16714-360 +1
Ethinyl Estradiol and NorgestrelMakes it, tests it, packages it and labels it Northstar Rx LLC. 16714-365
MesalamineMakes it, tests it, packages it and labels it Ingenus Pharmaceuticals, LLC 50742-371
MetforminMakes it, tests it, packages it and labels it Ingenus Pharmaceuticals, LLC 50742-633, 50742-634
MetoprololMakes it, tests it, packages it and labels it BluePoint Laboratories., Ingenus Pharmaceuticals, LLC 68001-356, 68001-357, 68001-358 +5
NifedipineMakes it, tests it, packages it and labels it Ingenus Pharmaceuticals, LLC 50742-260, 50742-261, 50742-262 +3
NorethindroneMakes it, tests it, packages it and labels it Ingenus Pharmaceuticals, LLC, Northstar Rx LLC. 50742-267, 16714-440, 16714-441
PramipexoleMakes it, tests it, packages it and labels it Ingenus Pharmaceuticals, LLC 50742-331, 50742-332, 50742-333 +4
ProgesteroneMakes it, tests it and packages it Ingenus Pharmaceuticals, LLC 50742-359
QuetiapineMakes it, tests it, packages it and labels it Ingenus Pharmaceuticals, LLC 50742-635, 50742-636, 50742-637 +2

FDA inspection history

EndedResultProgramProblems noted
Jul 14, 2023Problems found, fixed voluntarilyDrug Quality Assurance—
Jul 13, 2018No problems foundDrug Quality Assurance—
Apr 15, 2016No problems foundBioresearch Monitoring—
Jun 5, 2015No problems foundDrug Quality Assurance—
Mar 29, 2013No problems foundDrug Quality Assurance—

Registered with FDA for: analysis; label; manufacture; pack.