GlaxoSmithKline Manufacturing SpA
Form 483 issued November 12, 2021 · Torrile, Italy
- Inspection
- Nov 8 – Nov 12, 2021
- Investigator
- Michael R. Shanks
- Observations
- 1
- Pages
- 3
- FEI number
- 3002807114
In short: On November 12, 2021, FDA issued a Form 483 with 1 observation to GlaxoSmithKline Manufacturing SpA in Torrile, Parma (FEI 3002807114) after an inspection that ran Nov 8 – Nov 12, 2021. The investigator was Michael R. Shanks. Most observations concern production; the most-cited regulation is 21 CFR 211.113 (control of microbiological contamination).
At a glance
1 of 1 observations on this 483 concern production.
Most cited: 21 CFR 211.113 (1×) · 211.100 (1×)
What FDA observed
Preview: the opening words of each observationDashed: section inferred by FDA Intel and checked against the regulation text
- 01
Standard Operating Procedures are not followed or are not adequate in…
This inspection in context
Michael R. Shanks
27 documents · 2017–2024
Cites 211.113 (control of microbiological contamination) more than any other section. Most of their documents are for sites in California.
The firmGlaxoSmithKline Manufacturing SpA 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 GlaxoSmithKline Manufacturing SpA?
FDA listed 1 observation on this Form 483, mostly about production. 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 GlaxoSmithKline Manufacturing SpA?
Michael R. Shanks is named on this Form 483, for the inspection of Nov 8 – Nov 12, 2021. Each investigator has a profile showing what they cite most.
When was GlaxoSmithKline Manufacturing SpA inspected by FDA?
The inspection ran Nov 8 – Nov 12, 2021, and the Form 483 is dated November 12, 2021.
How do I get the full Form 483 for GlaxoSmithKline Manufacturing SpA?
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.