Form 483 · FEI 3003121577
Form 483 issued September 9, 2022 · Martorelles, Spain
- Inspection
- Sep 5 – Sep 9, 2022
- Investigator
- Susan O. Oladeji
- Observations
- 4
- Pages
- 2
- FEI number
- 3003121577
In short: On September 9, 2022, FDA issued a Form 483 with 4 observations to an FDA-inspected site in Martorelles, Spain (FEI 3003121577) after an inspection that ran Sep 5 – Sep 9, 2022. The investigator was Susan O. Oladeji. Most observations concern quality system and facilities & equipment; the most-cited regulation is 21 CFR 211.192 (production record review).
At a glance
3 of 4 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
Written procedures describing the handling of all written and oral complaints do not include provisions for…
- 03
Observation 3: scanned text, readable in the full document.
- 04
The procedures for the annual quality standards record evaluation are deficient in that they do not…
This inspection in context
Susan O. Oladeji
15 documents · 2017–2024
Cites 211.192 (production record review) more than any other section. Most of their documents are for sites in Georgia.
The firmSite 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 an FDA-inspected site?
FDA listed 4 observations on this Form 483, mostly about quality system and facilities & equipment. The most-cited regulation is 21 CFR 211.192 (production record review). The opening words of each observation are shown on this page.
Who inspected an FDA-inspected site?
Susan O. Oladeji is named on this Form 483, for the inspection of Sep 5 – Sep 9, 2022. Each investigator has a profile showing what they cite most.
When was an FDA-inspected site inspected by FDA?
The inspection ran Sep 5 – Sep 9, 2022, and the Form 483 is dated September 9, 2022.
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.