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FDA Inspection
•Lambda SpA•October 19, 2023

Lambda SpA – FDA Inspection, Oct 19, 2023

Record Details

This FDA Inspection record concerns Lambda SpA, with an inspection on October 19, 2023, issued by the Office of Inspections and Investigations.

Company
Lambda SpA
Inspection Date
October 19, 2023
Office
Office of Inspections and Investigations
Person
  • Gamal A. Norton (Issuing Officer)
View Company Profile

ID · dbfb7cf9-7060-4e5d-8956-85f3f8e5480c

Inspection Facts

Inspection number
1221088
FDA center
Medical Devices & Rad Health
Outcome
Form 483 issued

FDA Citations

4
  1. 21 CFR 820.120Lack of or inadequate procedures for labeling
  2. 21 CFR 820.50(a)(1)Documented evaluation
  3. 21 CFR 820.75(a)Documentation
  4. 21 CFR 820.80(c)Lack of or inadequate In-process acceptance procedures

Full citation text and observation details available on the Dashboard.

Other FDA inspections of Lambda SpA

3
DateClassificationOfficeProject area
May 28, 2026Not classifiedOffice of Inspections and InvestigationsCompliance: Devices
July 27, 2017Not classifiedOffice of Inspections and InvestigationsCompliance: Devices
May 17, 2013VAICenter for Devices and Radiological HealthCompliance: Devices
Other documents for Lambda SpA
  • FDA Inspection 1319174 - 2026-05-28
  • FDA Inspection 1020377 - 2017-07-27
  • FDA Inspection 832267 - 2013-05-17

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