GlaxoSmithKline Manufacturing SpA FDA Inspection Record
GlaxoSmithKline Manufacturing SpA is an FDA-registered facility (FEI 3002807114) located in Parma, IT. Registered operations: ANALYSIS; API MANUFACTURE; LABEL; MANUFACTURE; PACK; STERILIZE. RegDataLab tracks 7 FDA inspections at this facility.
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What FDA found at this site
- Latest inspection
- Oct 26, 2023: Voluntary Action Indicated (VAI)
- Inspections on record
- 7 (3 VAI, 4 NAI)
- 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
- Import refusals
- 8
Inspections and what FDA cited
| Date | Result | What FDA cited |
|---|---|---|
| Oct 26, 2023 | Voluntary Action Indicated (VAI) | No citations listed |
| Sep 29, 2017 | Voluntary Action Indicated (VAI) | No citations listed |
| Jul 22, 2016 | No Action Indicated (NAI) | No citations listed |
| May 27, 2015 | Voluntary Action Indicated (VAI) | Approve or reject components, products (21 CFR 211.22(a)) Approve or reject procedures or specs (21 CFR 211.22(c)) Cleaning / Sanitizing / Maintenance (21 CFR 211.67(a)) Procedures for sterile drug products (21 CFR 211.113(b)) and 4 more |
| Jul 10, 2013 | No Action Indicated (NAI) | No citations listed |
| Sep 21, 2012 | No Action Indicated (NAI) | No citations listed |
| Jun 28, 2011 | No Action Indicated (NAI) | No citations listed |
Facility details
- Company
- GlaxoSmithKline Manufacturing S.P.A.
- Location
- Parma (IT)
- Registration Expires
- Dec 31, 2026
- Operations
- ANALYSIS; API MANUFACTURE; LABEL; MANUFACTURE; PACK; STERILIZE
- Source
- decrs