Opti Source International
Form 483 issued April 4, 2024 · Bellport, New York
- Inspection
- Apr 1 – Apr 4, 2024
- Investigator
- Vivin George
- Observations
- 11
- Pages
- 10
- FEI number
- 3004507660
In short: On April 4, 2024, FDA issued a Form 483 with 11 observations to Opti Source International in Bellport, New York (FEI 3004507660) after an inspection that ran Apr 1 – Apr 4, 2024. The investigator was Vivin George. Most observations concern quality system and materials; the most-cited regulation is 21 CFR 211.84 (testing and approval or rejection of components, drug product containers, and closures).
At a glance
Observations span 4 systems, led by quality system.
What FDA observed
Preview: the opening words of each observation- 01
Failure to reject any lot of components that did not meet the appropriate written specifications for…
- 02
There is no quality…
- 03
Testing and release of drug product for distribution do not include appropriate laboratory determination of satisfactory…
- 04
Drug product component testing is deficient in that at least one specific test to verify the…
This inspection in context
Vivin George
20 documents · 2019–2025
Cites 211.100 (written procedures; deviations) more than any other section. Most of their documents are for sites in New York.
The firmOpti Source International history
The site's inspection history, in date order.
Similar 483sOther sites cited under 211.84(e)
See how FDA wrote the same problem up elsewhere.
Questions about this 483
What did FDA find at Opti Source International?
FDA listed 11 observations on this Form 483, mostly about quality system, materials and laboratory controls. The most-cited regulation is 21 CFR 211.84 (testing and approval or rejection of components, drug product containers, and closures). The opening words of each observation are shown on this page.
Who inspected Opti Source International?
Vivin George is named on this Form 483, for the inspection of Apr 1 – Apr 4, 2024. Each investigator has a profile showing what they cite most.
When was Opti Source International inspected by FDA?
The inspection ran Apr 1 – Apr 4, 2024, and the Form 483 is dated April 4, 2024.
How do I get the full Form 483 for Opti Source International?
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.