Form 483 · FEI 3014784835
Form 483 issued March 3, 2023
- Inspection
- Feb 27 – Mar 3, 2023
- Observations
- 1
- Pages
- 1
- FEI number
- 3014784835
In short: On March 3, 2023, FDA issued a Form 483 with 1 observation to an FDA-inspected site (FEI 3014784835) after an inspection that ran Feb 27 – Mar 3, 2023. Most observations concern facilities & equipment; the most-cited regulation is 21 CFR 211.68 (automatic, mechanical, and electronic equipment).
At a glance
1 of 1 observations on this 483 concern facilities & equipment.
Most cited: 21 CFR 211.68 (1×)
What FDA observed
Preview: the opening words of each observationDashed: section inferred by FDA Intel and checked against the regulation text
- 01
Routine calibrations of mechanical measuring instruments are not performed…
This inspection in context
Questions about this 483
What did FDA find at an FDA-inspected site?
FDA listed 1 observation on this Form 483, mostly about facilities & equipment. The most-cited regulation is 21 CFR 211.68 (automatic, mechanical, and electronic equipment). The opening words of each observation are shown on this page.
When was an FDA-inspected site inspected by FDA?
The inspection ran Feb 27 – Mar 3, 2023, and the Form 483 is dated March 3, 2023.
How do I get the full Form 483 for an FDA-inspected site?
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.