Form 483 · FEI 3016774658
Form 483 issued November 8, 2024 · Clarence, New York
- Inspection
- Nov 4 – Nov 8, 2024
- Investigators
- Kara J. Wright· Lauren H. Augustyniak· Vivin George
- Observations
- 9
- Pages
- 9
- FEI number
- 3016774658
In short: On November 8, 2024, FDA issued a Form 483 with 9 observations to an FDA-inspected site in Clarence, New York (FEI 3016774658) after an inspection that ran Nov 4 – Nov 8, 2024. The investigators were Kara J. Wright, Lauren H. Augustyniak and Vivin George. 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 observation- 01
There is no quality…
- 02
Testing and release of drug product for distribution do not include appropriate laboratory determination of satisfactory…
- 03
Drug product component testing is deficient in that at least one specific test to verify the…
- 04
An adequate number of batches of each drug product are not tested to determine…
This inspection in context
Kara J. Wright
9 documents · 2024–2026
Cites 211.113 (control of microbiological contamination) more than any other section. Most of their documents are for sites in Ohio.
The firmSite 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(a)
See how FDA wrote the same problem up elsewhere.
Questions about this 483
What did FDA find at an FDA-inspected site?
FDA listed 9 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 an FDA-inspected site?
Kara J. Wright, Lauren H. Augustyniak and Vivin George are named on this Form 483, for the inspection of Nov 4 – Nov 8, 2024. Each investigator has a profile showing what they cite most.
When was an FDA-inspected site inspected by FDA?
The inspection ran Nov 4 – Nov 8, 2024, and the Form 483 is dated November 8, 2024.
How do I get the full Form 483 for an FDA-inspected site?
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.