MARS FISHCARE NORTH AMERICA, INC.
Form 483 issued April 7, 2023 · Chalfont, Pennsylvania
- Inspection
- Apr 3 – Apr 7, 2023
- Investigator
- Tekalign Wondimu
- Observations
- 6
- Pages
- 5
- FEI number
- 2514739
In short: On April 7, 2023, FDA issued a Form 483 with 6 observations to MARS FISHCARE NORTH AMERICA, INC. in Chalfont, Pennsylvania (FEI 2514739) after an inspection that ran Apr 3 – Apr 7, 2023. The investigator was Tekalign Wondimu. Most observations concern facilities & equipment and laboratory controls.
At a glance
Facilities & equipment and laboratory controls account for 5 of 6 observations.
What FDA observed
Preview: the opening words of each observation- 01
There is a failure to thoroughly review any unexplained discrepancy whether or not the batch…
- 02
Testing and release of drug product for distribution do not include appropriate laboratory determination of satisfactory…
- 03
Laboratory controls do not include the establishment of scientifically sound and appropriate test procedures designed to…
- 04
Equipment used in the manufacture, processing, packing or holding of drug products is not of appropriate…
This inspection in context
Tekalign Wondimu
12 documents · 2021–2026
Cites FDCA 501(a)(2)(A) (insanitary conditions) more than any other section. Most of their documents are for sites in Virginia.
The firmMARS FISHCARE NORTH AMERICA, INC. history
The site's inspection history, in date order.
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 MARS FISHCARE NORTH AMERICA, INC.?
FDA listed 6 observations on this Form 483, mostly about facilities & equipment, laboratory controls and quality system. The opening words of each observation are shown on this page.
Who inspected MARS FISHCARE NORTH AMERICA, INC.?
Tekalign Wondimu is named on this Form 483, for the inspection of Apr 3 – Apr 7, 2023. Each investigator has a profile showing what they cite most.
When was MARS FISHCARE NORTH AMERICA, INC. inspected by FDA?
The inspection ran Apr 3 – Apr 7, 2023, and the Form 483 is dated April 7, 2023.
How do I get the full Form 483 for MARS FISHCARE NORTH AMERICA, 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.