Velocity Pharma LLC
Form 483 issued October 23, 2020 · Farmingdale, New York
- Inspection
- Oct 15 – Oct 23, 2020
- Investigator
- Gam S. Zamil
- Observations
- 1
- Pages
- 2
In short: On October 23, 2020, FDA issued a Form 483 with 1 observation to Velocity Pharma LLC in Farmingdale, New York after an inspection that ran Oct 15 – Oct 23, 2020. The investigator was Gam S. Zamil. Most observations concern production; the most-cited regulation is 21 CFR 211.100 (written procedures; deviations).
At a glance
1 of 1 observations on this 483 concern production.
Most cited: 21 CFR 211.100 (1×)
What FDA observed
Preview: the opening words of each observationDashed: section inferred by FDA Intel and checked against the regulation text
- 01
There are no written procedures for production and process controls designed to assure that the drug…
This inspection in context
Gam S. Zamil
18 documents · 2016–2024
Cites 211.166 (stability testing) more than any other section. Most of their documents are for sites in New York.
The firmVelocity Pharma LLC history
All 3 documents on file for this site, in date order, with what was cited at each inspection.
Similar 483sOther sites cited under 211.100
See how FDA wrote the same problem up elsewhere.
Questions about this 483
What did FDA find at Velocity Pharma LLC?
FDA listed 1 observation on this Form 483, mostly about production. The most-cited regulation is 21 CFR 211.100 (written procedures; deviations). The opening words of each observation are shown on this page.
Who inspected Velocity Pharma LLC?
Gam S. Zamil is named on this Form 483, for the inspection of Oct 15 – Oct 23, 2020. Each investigator has a profile showing what they cite most.
When was Velocity Pharma LLC inspected by FDA?
The inspection ran Oct 15 – Oct 23, 2020, and the Form 483 is dated October 23, 2020.
How do I get the full Form 483 for Velocity Pharma 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.