Invaderm Corporation
Form 483 issued June 28, 2023 · Somerset, New Jersey
- Inspection
- Jun 13 – Jun 28, 2023
- Investigator
- James R. Birkenstamm
- Observations
- 6
- Pages
- 6
- FEI number
- 3010165760
In short: On June 28, 2023, FDA issued a Form 483 with 6 observations to Invaderm Corporation in Somerset, New Jersey (FEI 3010165760) after an inspection that ran Jun 13 – Jun 28, 2023. The investigator was James R. Birkenstamm. Most observations concern quality system and laboratory controls.
At a glance
Quality system and laboratory controls account for 4 of 6 observations.
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
Laboratory records do not include complete data derived from all tests, examinations and assay necessary to…
- 03
The use of instruments, apparatus, gauges and recording devices not meeting…
- 04
Equipment used in the manufacture, processing, packing or holding of drug products is not of appropriate…
This inspection in context
James R. Birkenstamm
12 documents · 2018–2026
Cites 211.22 (responsibilities of quality control unit) more than any other section. Most of their documents are for sites in New Jersey.
The firmInvaderm Corporation history
All 3 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 Invaderm Corporation?
FDA listed 6 observations on this Form 483, mostly about quality system, laboratory controls and facilities & equipment. The opening words of each observation are shown on this page.
Who inspected Invaderm Corporation?
James R. Birkenstamm is named on this Form 483, for the inspection of Jun 13 – Jun 28, 2023. Each investigator has a profile showing what they cite most.
When was Invaderm Corporation inspected by FDA?
The inspection ran Jun 13 – Jun 28, 2023, and the Form 483 is dated June 28, 2023.
How do I get the full Form 483 for Invaderm Corporation?
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.