InvaTech Pharma Solutions LLC
Form 483 issued February 7, 2019 · East Brunswick, New Jersey
- Inspection
- Jan 25 – Feb 7, 2019
- Observations
- 2
- Pages
- 1
- FEI number
- 3009964119
In short: On February 7, 2019, FDA issued a Form 483 with 2 observations to InvaTech Pharma Solutions LLC in East Brunswick, New Jersey (FEI 3009964119) after an inspection that ran Jan 25 – Feb 7, 2019. Most observations concern quality system; the most-cited regulation is 21 CFR 211.192 (production record review).
At a glance
2 of 2 observations on this 483 concern quality system.
Most cited: 21 CFR 211.192 (1×) · 211.25 (1×)
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 whether or not the batch…
- 02
GMP training is not conducted on a continuing basis to assure that employees remain familiar with…
This inspection in context
Questions about this 483
What did FDA find at InvaTech Pharma Solutions LLC?
FDA listed 2 observations on this Form 483, mostly about quality system. The most-cited regulation is 21 CFR 211.192 (production record review). The opening words of each observation are shown on this page.
When was InvaTech Pharma Solutions LLC inspected by FDA?
The inspection ran Jan 25 – Feb 7, 2019, and the Form 483 is dated February 7, 2019.
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.