Form 483 · FEI 3000186629
Form 483 issued March 5, 2020 · Monterrey, Mexico
- Inspection
- Mar 2 – Mar 5, 2020
- Observations
- 2
- Pages
- 1
- FEI number
- 3000186629
In short: On March 5, 2020, FDA issued a Form 483 with 2 observations to an FDA-inspected site in Monterrey, Nuevo Leon (FEI 3000186629) after an inspection that ran Mar 2 – Mar 5, 2020. Most observations concern facilities & equipment and laboratory controls; the most-cited regulation is 21 CFR 211.68 (automatic, mechanical, and electronic equipment).
At a glance
Facilities & equipment and laboratory controls account for 2 of 2 observations.
Most cited: 21 CFR 211.68 (1×) · 211.160 (1×)
What FDA observed
Preview: the opening words of each observationDashed: section inferred by FDA Intel and checked against the regulation text
- 01
Computerized systems should have sufficient controls to prevent unauthorized access or changes to data. There should…
- 02
There should be documented procedures describing sampling, testing, approval or rejection of materials, and recording and…
This inspection in context
Questions about this 483
What did FDA find at an FDA-inspected site?
FDA listed 2 observations on this Form 483, mostly about facilities & equipment and laboratory controls. 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 Mar 2 – Mar 5, 2020, and the Form 483 is dated March 5, 2020.
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.