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GlaxoSmithKline Vaccines Srl FDA Inspection Record

FEI 3006738517 · Inspections, Form 483s, warning letters and import refusals

GlaxoSmithKline Vaccines Srl is an FDA-registered facility (FEI 3006738517) located in SOVICILLE (ROSIA ), IT. Registered operations: ANALYSIS; LABEL; MANUFACTURE; PACK. RegDataLab tracks 5 FDA inspections at this facility.

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What FDA found at this site

Latest inspection: Jan 26, 2024: Voluntary Action Indicated (VAI)
Inspections on record: 5 (5 VAI)
Last OAI inspection: None on record
Warning letters: None matched to this FEI. Many letters do not state an FEI: search warning letters by company name
Form 483 and inspection documents: 1 in FDA's reading room
Recalls as the recalling firm: 2, latest Dec 2, 2013
Import refusals: 1

A Form 483 lists an inspector's observations. OAI means FDA recommends regulatory and/or administrative action. A warning letter is FDA's formal enforcement notice. No record here does not establish that a site is safe. Check this site on FDA's Data Dashboard.

Inspections and what FDA cited

Newest first. Citations are the inspector observations FDA publishes for the inspection.

Date	Result	What FDA cited
Jan 26, 2024	Voluntary Action Indicated (VAI)	Procedures not in writing, fully followed (21 CFR 211.22(d)) Training , Education , Experience overall (21 CFR 211.25(a)) Following/documenting laboratory controls (21 CFR 211.160(a)) Investigations of discrepancies, failures (21 CFR 211.192) and 1 more
Jun 6, 2019	Voluntary Action Indicated (VAI)	Cleaning / Sanitizing / Maintenance (21 CFR 211.67(a)) Cleaning SOPs/schedules (21 CFR 211.67(b)(2)) Procedures for sterile drug products (21 CFR 211.113(b)) Sampling/testing of labeling/packaging materials (21 CFR 211.122(a)) and 7 more
Jun 26, 2015	Voluntary Action Indicated (VAI)	No citations listed
Jun 18, 2013	Voluntary Action Indicated (VAI)	No citations listed
Jul 31, 2009	Voluntary Action Indicated (VAI)	No citations listed

Recalls

Newest first. Recalls FDA's Enforcement Report lists with this FEI as the recalling firm. The recalling firm is not always the site that made the product. Search FDA's Enforcement Report by recall number.

Date	Class	Recall	Product and reason
Dec 2, 2013	Class II	B-0214-15	Meningococcal Polysaccharide Vaccine, Groups A, C, Y, W135 Combined Lot of MENVEO Meningococcal (Groups A, C, Y and W-135) Oligosaccharide Diphtheria CRM-197 Conjugate Vaccine, with higher than specified…
Jul 10, 2013	Class II	B-1832-13	Meningococcal Polysaccharide Vaccine, Groups A, C, Y, W135 Combined Lot of MENVEO Meningococcal (Groups A, C, Y and W-135) Oligosaccharide Diphtheria CRM-197 Conjugate Vaccine, with higher than specified…

Form 483s and inspection documents

483 on FDA.gov
FDA listing date Jan 26, 2024, which is not always the inspection or issue date. Published by FDA Oct 20, 2026.

Facility details

Company: GlaxoSmithKline Vaccines Srl
Location: SOVICILLE (ROSIA ) (IT)
Registration Expires: Dec 31, 2026
Operations: ANALYSIS; LABEL; MANUFACTURE; PACK
Source: decrs