Form 483 · FEI 3017734754
Form 483 issued April 16, 2024 · ALCALA DE HENARES, Spain
- Inspection
- Oct 11, 2022 – Apr 16, 2024
- Investigators
- Marcus A. Ray· Ofthis Marcus A. Ray· Pratik S. Upadhyay
- Observations
- 11
- Pages
- 56
- FEI number
- 3017734754
In short: On April 16, 2024, FDA issued a Form 483 with 11 observations to an FDA-inspected site in ALCALA DE HENARES, Spain (FEI 3017734754) after an inspection that ran Oct 11, 2022 – Apr 16, 2024. The investigators were Marcus A. Ray, Ofthis Marcus A. Ray and Pratik S. Upadhyay. Most observations concern quality system and facilities & equipment; the most-cited regulation is 21 CFR 211.68 (automatic, mechanical, and electronic equipment).
At a glance
Observations span 4 systems, led by quality system.
Most cited: 21 CFR 211.68 (2×) · 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
REPEAT OBSERVATION Your firm failed to establish an adequate quality control unit with the responsibility and…
- 02
Investigations of an unexplained discrepancy into a failure of a batch or any of its components…
- 03
REPEAT OBSERVATION Employees engaged in the manufacture, processing, packing, holding of a drug product lack the…
- 04
Buildings used in the manufacture, processing, packing, or holding of a drug product to not the…
This inspection in context
Marcus A. Ray
14 documents · 2017–2025
Cites 211.160 (general requirements) more than any other section. Most of their documents are for sites in China.
The firmSite history
The site's inspection history, in date order.
Similar 483sOther sites cited under 211.68
See how FDA wrote the same problem up elsewhere.
Questions about this 483
What did FDA find at an FDA-inspected site?
FDA listed 11 observations on this Form 483, mostly about quality system, facilities & equipment and laboratory controls. The most-cited regulation is 21 CFR 211.68 (automatic, mechanical, and electronic equipment). The opening words of each observation are shown on this page.
Who inspected an FDA-inspected site?
Marcus A. Ray, Ofthis Marcus A. Ray and Pratik S. Upadhyay are named on this Form 483, for the inspection of Oct 11, 2022 – Apr 16, 2024. Each investigator has a profile showing what they cite most.
When was an FDA-inspected site inspected by FDA?
The inspection ran Oct 11, 2022 – Apr 16, 2024, and the Form 483 is dated April 16, 2024.
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.