InvaTech Pharma Solutions LLC
Form 483 issued June 9, 2023 · East Brunswick, New Jersey
- Inspection
- Jun 5 – Jun 9, 2023
- Investigator
- Syeda N. Mahazabin
- Observations
- 8
- Pages
- 10
- FEI number
- 3009964119
In short: On June 9, 2023, FDA issued a Form 483 with 8 observations to InvaTech Pharma Solutions LLC in East Brunswick, New Jersey (FEI 3009964119) after an inspection that ran Jun 5 – Jun 9, 2023. The investigator was Syeda N. Mahazabin. Most observations concern quality system and laboratory controls.
At a glance
Observations span 4 systems, led by quality system.
What FDA observed
Preview: the opening words of each observation- 01
There is a failure to thoroughly review any unexplained discrepancy and the failure of a batch…
- 02
The responsibilities and procedures applicable to the quality control unit…
- 03
Control procedures are not established which monitor the output and validate the performance of those manufacturing…
- 04
Acceptance criteria for the sampling and testing conducted by the quality control unit is not adequate…
This inspection in context
Syeda N. Mahazabin
19 documents · 2006–2026
Cites 211.67 (equipment cleaning and maintenance) more than any other section. Most of their documents are for sites in New York.
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 8 observations on this Form 483, mostly about quality system, laboratory controls and production. The opening words of each observation are shown on this page.
Who inspected InvaTech Pharma Solutions LLC?
Syeda N. Mahazabin is named on this Form 483, for the inspection of Jun 5 – Jun 9, 2023. Each investigator has a profile showing what they cite most.
When was InvaTech Pharma Solutions LLC inspected by FDA?
The inspection ran Jun 5 – Jun 9, 2023, and the Form 483 is dated June 9, 2023.
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.