Ercros SA
Form 483 issued November 22, 2024 · Aranjuez, Spain
- Inspection
- Nov 14 – Nov 22, 2024
- Observations
- 9
- Pages
- 8
- FEI number
- 3003562118
In short: On November 22, 2024, FDA issued a Form 483 with 9 observations to Ercros SA in Aranjuez, Spain (FEI 3003562118) after an inspection that ran Nov 14 – Nov 22, 2024. The investigators were Damaris Y. Hernandez, Neeeee Damaris Hernandez and Satins Oe Damaris Hernandez. Most observations concern quality system and facilities & equipment; the most-cited regulation is 21 CFR 211.42 (design and construction features).
At a glance
Observations span 3 systems, led by quality system.
Most cited: 21 CFR 211.42 (2×) · 211.22 (2×)
What FDA observed
Preview: the opening words of each observationDashed: section inferred by FDA Intel and checked against the regulation text
- 01
1. The Grade A (ISO 5) filling zones of manufacturing Room which are protected by a…
- 02
The current aseptic process simulations (media fills) do not simulate the actual commercial aseptic filling process…
- 03
Your Quality Unit does not perform a comprehensive periodic evaluation (i.e., cumulative assessment) of Non- Viable…
- 04
Your airflow simulatios janufacturing Rooms sed to manufacture the following drug substances sterile d sterile espectively…
This inspection in context
Damaris Y. Hernandez
17 documents · 2022–2026
Cites 211.22 (responsibilities of quality control unit) more than any other section. Most of their documents are for sites in Florida.
The firmErcros SA history
All 3 documents on file for this site, in date order, with what was cited at each inspection.
Similar 483sOther sites cited under 211.42
See how FDA wrote the same problem up elsewhere.
Questions about this 483
What did FDA find at Ercros SA?
FDA listed 9 observations on this Form 483, mostly about quality system, facilities & equipment and production. The most-cited regulation is 21 CFR 211.42 (design and construction features). The opening words of each observation are shown on this page.
Who inspected Ercros SA?
Damaris Y. Hernandez, Neeeee Damaris Hernandez and Satins Oe Damaris Hernandez are named on this Form 483, for the inspection of Nov 14 – Nov 22, 2024. Each investigator has a profile showing what they cite most.
When was Ercros SA inspected by FDA?
The inspection ran Nov 14 – Nov 22, 2024, and the Form 483 is dated November 22, 2024.
How do I get the full Form 483 for Ercros SA?
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.