Form 483 · FEI 3001748505
Form 483 issued July 28, 2023 · Bianya, Spain
- Inspection
- Jul 21 – Jul 28, 2023
- Observations
- 3
- Pages
- 4
- FEI number
- 3001748505
In short: On July 28, 2023, FDA issued a Form 483 with 3 observations to an FDA-inspected site in Bianya, Gerona (FEI 3001748505) after an inspection that ran Jul 21 – Jul 28, 2023. Most observations concern production.
At a glance
3 of 3 observations on this 483 concern production.
What FDA observed
Preview: the opening words of each observation- 01
Procedures designed to prevent microbiological contamination of drug products purporting to be sterile did not include…
- 02
Control procedures are not established which monitor the output and validate the performance of those manufacturing…
- 03
The batch production and control records are deficient in that they do not include documentation of…
This inspection in context
Questions about this 483
What did FDA find at an FDA-inspected site?
FDA listed 3 observations on this Form 483, mostly about production. The opening words of each observation are shown on this page.
When was an FDA-inspected site inspected by FDA?
The inspection ran Jul 21 – Jul 28, 2023, and the Form 483 is dated July 28, 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.