VIANT PUERTO RICO, INC.
Form 483 issued May 2, 2025 · Vega Baja, Puerto Rico
- Inspection
- Apr 28 – May 2, 2025
- Investigator
- Yoriann M. Cabrera Bartolomei
- Observations
- 2
- Pages
- 16
- FEI number
- 3010356072
In short: On May 2, 2025, FDA issued a Form 483 with 2 observations to VIANT PUERTO RICO, INC. in Vega Baja, Puerto Rico (FEI 3010356072) after an inspection that ran Apr 28 – May 2, 2025. The investigator was Yoriann M. Cabrera Bartolomei. Most observations concern quality system; the most-cited regulation is 21 CFR 211.22 (responsibilities of quality control unit).
At a glance
2 of 2 observations on this 483 concern quality system.
What FDA observed
Preview: the opening words of each observationDashed: section inferred by FDA Intel and checked against the regulation text
- 01
There is a failure to thoroughly review any unexplained discrepancy whether or not the batch…
- 02
The responsibilities and procedures applicable to the quality control unit…
This inspection in context
Yoriann M. Cabrera Bartolomei
8 documents · 2023–2025
Cites 211.22 (responsibilities of quality control unit) more than any other section. Most of their documents are for sites in New Jersey.
The firmVIANT PUERTO RICO, 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 VIANT PUERTO RICO, INC.?
FDA listed 2 observations on this Form 483, mostly about quality system. The most-cited regulation is 21 CFR 211.22 (responsibilities of quality control unit). The opening words of each observation are shown on this page.
Who inspected VIANT PUERTO RICO, INC.?
Yoriann M. Cabrera Bartolomei is named on this Form 483, for the inspection of Apr 28 – May 2, 2025. Each investigator has a profile showing what they cite most.
When was VIANT PUERTO RICO, INC. inspected by FDA?
The inspection ran Apr 28 – May 2, 2025, and the Form 483 is dated May 2, 2025.
How do I get the full Form 483 for VIANT PUERTO RICO, 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.