Scientific Solutions Global LLC
Form 483 issued January 2, 2019 · Carle Place, New York
- Inspection
- Dec 11, 2018 – Jan 2, 2019
- Investigator
- Jay T. Wong
- Observations
- 12
- Pages
- 5
- FEI number
- 3013847493
In short: On January 2, 2019, FDA issued a Form 483 with 12 observations to Scientific Solutions Global LLC in Carle Place, New York (FEI 3013847493) after an inspection that ran Dec 11, 2018 – Jan 2, 2019. The investigator was Jay T. Wong. Most observations concern quality system and laboratory controls.
At a glance
Observations span 4 systems, led by quality system.
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
Testing and release of drug product for distribution do not include appropriate laboratory determination of satisfactory…
- 03
There is no written testing program designed to assess the stability…
- 04
Control procedures are not established which monitor the output and validate the performance of those manufacturing…
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 firmScientific Solutions Global LLC history
All 2 documents on file for this site, in date order, with what was cited at each inspection.
Similar 483sOther sites cited under 211.22
See how FDA wrote the same problem up elsewhere.
Questions about this 483
What did FDA find at Scientific Solutions Global LLC?
FDA listed 12 observations on this Form 483, mostly about quality system, laboratory controls and production. The opening words of each observation are shown on this page.
Who inspected Scientific Solutions Global LLC?
Jay T. Wong is named on this Form 483, for the inspection of Dec 11, 2018 – Jan 2, 2019. Each investigator has a profile showing what they cite most.
When was Scientific Solutions Global LLC inspected by FDA?
The inspection ran Dec 11, 2018 – Jan 2, 2019, and the Form 483 is dated January 2, 2019.
How do I get the full Form 483 for Scientific Solutions Global LLC?
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.