INVAHEALTH INC.
Form 483 issued December 15, 2021 · CRANBURY, New Jersey
- Inspection
- Dec 7 – Dec 15, 2021
- Observations
- 3
- Pages
- 4
- FEI number
- 3015265848
In short: On December 15, 2021, FDA issued a Form 483 with 3 observations to INVAHEALTH INC. in CRANBURY, New Jersey (FEI 3015265848) after an inspection that ran Dec 7 – Dec 15, 2021. Most observations concern facilities & equipment and packaging & labeling.
At a glance
Facilities & equipment and packaging & labeling account for 2 of 3 observations.
What FDA observed
Preview: the opening words of each observation- 01
Appropriate controls are not exercised over computers or related systems to assure that changes in master…
- 02
Results of inspection of packaging and labeling facilities are not documented in…
- 03
The batch production and control records are deficient in that they do not include documentation of…
This inspection in context
Questions about this 483
What did FDA find at INVAHEALTH INC.?
FDA listed 3 observations on this Form 483, mostly about facilities & equipment, packaging & labeling and production. The opening words of each observation are shown on this page.
When was INVAHEALTH INC. inspected by FDA?
The inspection ran Dec 7 – Dec 15, 2021, and the Form 483 is dated December 15, 2021.
How do I get the full Form 483 for INVAHEALTH INC.?
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.