Ercros SA
Form 483 issued December 14, 2018 · Aranjuez, Spain
- Inspection
- Dec 10 – Dec 14, 2018
- Observations
- 7
- Pages
- 3
- FEI number
- 3003562118
In short: On December 14, 2018, FDA issued a Form 483 with 7 observations to Ercros SA in Aranjuez, Spain (FEI 3003562118) after an inspection that ran Dec 10 – Dec 14, 2018. 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 5 of 7 observations.
Most cited: 21 CFR 211.160 (2×)
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 or the failure of a batch…
- 02
Process validation ERCROS-V-07/15 (b)(4) Validation Report" Rev. 1 approved on 6/25/15 and ERCROS-V-17/15 "Validacion del Proceso…
- 03
Your Quality Unit failed to place (b)(4) lot (b)(4) on long-term stability after re-working it twice…
- 04
The (b)(4) control system used for the manufacturing of (b)(4) is not adequately validated in that…
This inspection in context
Questions about this 483
What did FDA find at Ercros SA?
FDA listed 7 observations on this Form 483, mostly about laboratory controls, facilities & equipment and quality system. The most-cited regulation is 21 CFR 211.160 (general requirements). The opening words of each observation are shown on this page.
When was Ercros SA inspected by FDA?
The inspection ran Dec 10 – Dec 14, 2018, and the Form 483 is dated December 14, 2018.
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.