Form 483 · FEI 3004258511
Form 483 issued August 4, 2023 · Villa Loma Hermosa, Argentina
- Inspection
- Jul 31 – Aug 4, 2023
- Observations
- 2
- Pages
- 2
- FEI number
- 3004258511
In short: On August 4, 2023, FDA issued a Form 483 with 2 observations to an FDA-inspected site in Villa Loma Hermosa, Buenos Aires (FEI 3004258511) after an inspection that ran Jul 31 – Aug 4, 2023. Most observations concern laboratory controls and facilities & equipment; the most-cited regulation is 21 CFR 211.160 (general requirements).
At a glance
Laboratory controls and facilities & equipment account for 2 of 2 observations.
Most cited: 21 CFR 211.160(b) (1×) · 211.42(c) (1×)
What FDA observed
Preview: the opening words of each observation- 01
Laboratory controls do not include the establishment of scientifically sound and appropriate specifications and test procedures…
- 02
The separate or defined areas necessary to prevent contamination or mix-ups are deficient. euriorens)…
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 laboratory controls and facilities & equipment. The most-cited regulation is 21 CFR 211.160 (general requirements). The opening words of each observation are shown on this page.
When was an FDA-inspected site inspected by FDA?
The inspection ran Jul 31 – Aug 4, 2023, and the Form 483 is dated August 4, 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.