DavetVelocity Pharma Llc
Form 483 issued May 18, 2016 · Farmingdale, New York
- Inspection
- May 16 – May 18, 2016
- Investigators
- Jose O. Hernandez· Sony Mathews
- Observations
- 6
- Pages
- 5
In short: On May 18, 2016, FDA issued a Form 483 with 6 observations to DavetVelocity Pharma Llc in Farmingdale, New York after an inspection that ran May 16 – May 18, 2016. The investigators were Jose O. Hernandez and Sony Mathews. Most observations concern packaging & labeling and laboratory controls; the most-cited regulation is 21 CFR 211.130 (packaging and labeling operations).
At a glance
5 of 6 observations on this 483 concern packaging & labeling.
Most cited: 21 CFR 211.130 (3×)
What FDA observed
Preview: the opening words of each observationDashed: section inferred by FDA Intel and checked against the regulation text
- 01
Inspection of the packaging and labeling facilities immediately before use is not done to assure that…
- 02
Inspection of the facilities is not done after use to assure that materials not suitable for…
- 03
Strict control is not exercised over labeling issued for use in…
- 04
The packaging and labeling operation for cut labels which relies on the use of electronic or…
This inspection in context
Jose O. Hernandez
12 documents · 2015–2020
Cites 211.160 (general requirements) more than any other section. Most of their documents are for sites in New York.
The firmDavetVelocity Pharma Llc history
The site's inspection history, in date order.
Similar 483sOther sites cited under 211.130
See how FDA wrote the same problem up elsewhere.
Questions about this 483
What did FDA find at DavetVelocity Pharma Llc?
FDA listed 6 observations on this Form 483, mostly about packaging & labeling and laboratory controls. The most-cited regulation is 21 CFR 211.130 (packaging and labeling operations). The opening words of each observation are shown on this page.
Who inspected DavetVelocity Pharma Llc?
Jose O. Hernandez and Sony Mathews are named on this Form 483, for the inspection of May 16 – May 18, 2016. Each investigator has a profile showing what they cite most.
When was DavetVelocity Pharma Llc inspected by FDA?
The inspection ran May 16 – May 18, 2016, and the Form 483 is dated May 18, 2016.
How do I get the full Form 483 for DavetVelocity 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.