InvaTech Pharma Solutions LLC
Form 483 issued April 4, 2017 · East Brunswick, New Jersey
- Inspection
- Mar 21 – Apr 4, 2017
- Investigator
- Frederick Razzaghi
- Observations
- 4
- Pages
- 2
- FEI number
- 3009964119
In short: On April 4, 2017, FDA issued a Form 483 with 4 observations to InvaTech Pharma Solutions LLC in East Brunswick, New Jersey (FEI 3009964119) after an inspection that ran Mar 21 – Apr 4, 2017. The investigator was Frederick Razzaghi. Most observations concern laboratory controls and production.
At a glance
Laboratory controls and production account for 4 of 4 observations.
What FDA observed
Preview: the opening words of each observationDashed: section inferred by FDA Intel and checked against the regulation text
- 01
Laboratory controls do not include the establishment of scientifically sound and appropriate specifications and test procedures…
- 02
There are no written procedures for production and process controls designed to assure that the drug…
- 03
Laboratory records do not include complete data derived from all tests, examinations and assay necessary to…
- 04
Actual yield and percentages of theoretical yield are not determined at the conclusion of each appropriate…
This inspection in context
Frederick Razzaghi
15 documents · 2014–2024
Cites 211.42 (design and construction features) more than any other section. Most of their documents are for sites in New Jersey.
The firmInvaTech Pharma Solutions LLC history
All 4 documents on file for this site, in date order, with what was cited at each inspection.
Similar 483sOther sites cited under 211.160
See how FDA wrote the same problem up elsewhere.
Questions about this 483
What did FDA find at InvaTech Pharma Solutions LLC?
FDA listed 4 observations on this Form 483, mostly about laboratory controls and production. The opening words of each observation are shown on this page.
Who inspected InvaTech Pharma Solutions LLC?
Frederick Razzaghi is named on this Form 483, for the inspection of Mar 21 – Apr 4, 2017. Each investigator has a profile showing what they cite most.
When was InvaTech Pharma Solutions LLC inspected by FDA?
The inspection ran Mar 21 – Apr 4, 2017, and the Form 483 is dated April 4, 2017.
How do I get the full Form 483 for InvaTech Pharma Solutions 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.