Wyeth Farma SA
Form 483 issued November 22, 2024 · San Sebastian de los Reyes, Spain
- Inspection
- Nov 11 – Nov 22, 2024
- Investigators
- Lewis K. Antwi· Travis S. Bradley
- Observations
- 2
- Pages
- 4
- FEI number
- 3003973260
In short: On November 22, 2024, FDA issued a Form 483 with 2 observations to Wyeth Farma SA in San Sebastian de los Reyes, M (FEI 3003973260) after an inspection that ran Nov 11 – Nov 22, 2024. The investigators were Lewis K. Antwi and Travis S. Bradley. Most observations concern production and quality system; the most-cited regulation is 21 CFR 211.113 (control of microbiological contamination).
At a glance
Production and quality system account for 2 of 2 observations.
Most cited: 21 CFR 211.113 (1×) · 211.192 (1×)
What FDA observed
Preview: the opening words of each observationDashed: section inferred by FDA Intel and checked against the regulation text
- 01
Procedures designed to prevent microbiological contamination of drug products purporting to be sterile are…
- 02
There is a failure to thoroughly review any unexplained discrepancy whether or not the batch…
This inspection in context
Lewis K. Antwi
11 documents · 2019–2025
Cites 211.192 (production record review) more than any other section. Most of their documents are for sites in Pennsylvania.
The firmWyeth Farma SA history
The site's inspection history, in date order.
Similar 483sOther sites cited under 211.113
See how FDA wrote the same problem up elsewhere.
Questions about this 483
What did FDA find at Wyeth Farma SA?
FDA listed 2 observations on this Form 483, mostly about production and quality system. The most-cited regulation is 21 CFR 211.113 (control of microbiological contamination). The opening words of each observation are shown on this page.
Who inspected Wyeth Farma SA?
Lewis K. Antwi and Travis S. Bradley are named on this Form 483, for the inspection of Nov 11 – Nov 22, 2024. Each investigator has a profile showing what they cite most.
When was Wyeth Farma SA inspected by FDA?
The inspection ran Nov 11 – Nov 22, 2024, and the Form 483 is dated November 22, 2024.
How do I get the full Form 483 for Wyeth Farma 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.