MediWound Ltd.
Form 483 issued November 15, 2022 · Yavne, Israel
- Inspection
- Nov 7 – Nov 15, 2022
- Investigators
- Andrea Franco· Esther C. Broner· Michael R. Shanks
- Observations
- 5
- Pages
- 3
- FEI number
- 3003889199
In short: On November 15, 2022, FDA issued a Form 483 with 5 observations to MediWound Ltd. in Yavne, Israel (FEI 3003889199) after an inspection that ran Nov 7 – Nov 15, 2022. The investigators were Andrea Franco, Esther C. Broner and Michael R. Shanks. Most observations concern production and facilities & equipment; the most-cited regulation is 21 CFR 211.113 (control of microbiological contamination).
At a glance
Production and facilities & equipment account for 3 of 5 observations.
Most cited: 21 CFR 211.113 (2×)
What FDA observed
Preview: the opening words of each observationDashed: section inferred by FDA Intel and checked against the regulation text
- 01
Environmental and personnel monitoring of aseptic processing areas following critical Grade A…
- 02
Aseptic processing areas are deficient regarding microbial cross contamination techniques/controls. During Filling Line setup and filling…
- 03
Your firm’s cleaning and sanitization program is deficient to prevent the introduction of microbial contamination into…
- 04
Your firm’s quality oversite is inadequate. Your process for assessing and identifying risks pertaining to microbial…
This inspection in context
Andrea Franco
5 documents · 2017–2025
Cites 211.113 (control of microbiological contamination) more than any other section. Most of their documents are for sites in Ireland.
The firmMediWound Ltd. 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 MediWound Ltd.?
FDA listed 5 observations on this Form 483, mostly about production, facilities & equipment 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 MediWound Ltd.?
Andrea Franco, Esther C. Broner and Michael R. Shanks are named on this Form 483, for the inspection of Nov 7 – Nov 15, 2022. Each investigator has a profile showing what they cite most.
When was MediWound Ltd. inspected by FDA?
The inspection ran Nov 7 – Nov 15, 2022, and the Form 483 is dated November 15, 2022.
How do I get the full Form 483 for MediWound Ltd.?
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.