InvaTech Pharma Solutions LLC
Form 483 issued December 28, 2017 · East Brunswick, New Jersey
- Inspection
- Dec 18 – Dec 28, 2017
- Investigator
- Russell J. Glapion
- Observations
- 3
- Pages
- 3
- FEI number
- 3009964119
In short: On December 28, 2017, FDA issued a Form 483 with 3 observations to InvaTech Pharma Solutions LLC in East Brunswick, New Jersey (FEI 3009964119) after an inspection that ran Dec 18 – Dec 28, 2017. The investigator was Russell J. Glapion. Most observations concern production and quality system.
At a glance
2 of 3 observations on this 483 concern production.
What FDA observed
Preview: the opening words of each observationDashed: section inferred by FDA Intel and checked against the regulation text
- 01
There is a failure to thoroughly review any unexplained discrepancy and the failure of a batch…
- 02
Time limits are not established when appropriate for the completion of each production phase to assure…
- 03
Actual yield and percentages of theoretical yield are not determined at the conclusion of each appropriate…
This inspection in context
Russell J. Glapion
18 documents · 2013–2021
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 211.192
See how FDA wrote the same problem up elsewhere.
Questions about this 483
What did FDA find at InvaTech Pharma Solutions LLC?
FDA listed 3 observations on this Form 483, mostly about production and quality system. The opening words of each observation are shown on this page.
Who inspected InvaTech Pharma Solutions LLC?
Russell J. Glapion is named on this Form 483, for the inspection of Dec 18 – Dec 28, 2017. Each investigator has a profile showing what they cite most.
When was InvaTech Pharma Solutions LLC inspected by FDA?
The inspection ran Dec 18 – Dec 28, 2017, and the Form 483 is dated December 28, 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.