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•United States

One Lambda Inc, West Hills, CA – FDA Inspections

Inspection records and compliance data for One Lambda Inc in West Hills, California. 4 FDA inspections on record, 1 Form 483, last inspected February 10, 2017.

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Company Profile

This profile covers One Lambda Inc based in West Hills, California, United States.

FDA Inspection History

FDA inspections
4
OAI
0
VAI
1
NAI
2
Unclassified
1
Form 483s
1
Warning letters
0

First inspected July 13, 2011. Last inspected February 10, 2017.

Most cited issue areas

  • Acceptance status1 inspection
  • Complaints1 inspection
  • Lack/Inad procedure-Monitoring/Control of Validated Proces1 inspection

FDA inspections (4)

DateResultFDA center(s)Insp. #
February 10, 2017Not classifiedMedical Devices & Rad Health1028992
May 18, 2016VAIBiologics, Medical Devices & Rad Health · Compliance: Devices975304
September 10, 2014NAIBiologics, Medical Devices & Rad Health · Compliance: Devices896974
July 13, 2011NAIBiologics, Medical Devices & Rad Health · Compliance: Devices734327
FDA documents

No Form 483s, Warning Letters or EIRs on record.

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Organogenesis, Inc.
Excel Regenerative Solutions
Innovasis, Inc
Company Information

Name

One Lambda Inc

FEI Number

2024375

Address

22801 Roscoe Blvd, West Hills, California 91304-3200, United States

Country

United States

ID: ba66629f-3f99-44ae-ab6c-09bc47f957ce

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