Pro-Blending LLC
Form 483 issued February 5, 2020 · Linden, New Jersey
- Inspection
- Jan 21 – Feb 5, 2020
- Investigator
- Yvesna Blaise
- Observations
- 9
- Pages
- 6
- FEI number
- 3006791485
In short: On February 5, 2020, FDA issued a Form 483 with 9 observations to Pro-Blending LLC in Linden, New Jersey (FEI 3006791485) after an inspection that ran Jan 21 – Feb 5, 2020. The investigator was Yvesna Blaise. Most observations concern laboratory controls and production.
At a glance
Laboratory controls and production account for 6 of 9 observations.
What FDA observed
Preview: the opening words of each observation- 01
There is no quality…
- 02
Written procedures are not established and followed for the cleaning and maintenance of equipment, including utensils…
- 03
Testing and release of drug product for distribution do not include appropriate laboratory determination of satisfactory…
- 04
Drug products do not bear an expiration date determined by appropriate stability data to assure they…
This inspection in context
Yvesna Blaise
8 documents · 2016–2020
Cites 211.165 (testing and release for distribution) more than any other section. Most of their documents are for sites in New Jersey.
The firmPro-Blending LLC history
The site's inspection history, in date order.
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 Pro-Blending LLC?
FDA listed 9 observations on this Form 483, mostly about laboratory controls, production and quality system. The opening words of each observation are shown on this page.
Who inspected Pro-Blending LLC?
Yvesna Blaise is named on this Form 483, for the inspection of Jan 21 – Feb 5, 2020. Each investigator has a profile showing what they cite most.
When was Pro-Blending LLC inspected by FDA?
The inspection ran Jan 21 – Feb 5, 2020, and the Form 483 is dated February 5, 2020.
How do I get the full Form 483 for Pro-Blending 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.