Company
United StatesInternational Sterilization Laboratory, LLC, Groveland, FL – FDA Inspections
Inspection records and compliance data for International Sterilization Laboratory, LLC in Groveland, Florida. 5 FDA inspections on record, last inspected December 07, 2023.
Company Profile
This profile covers International Sterilization Laboratory, LLC based in Groveland, Florida, United States.
FDA Inspection History
- FDA inspections
- 5
- OAI
- 0
- VAI
- 4
- NAI
- 1
- Form 483s
- 0
- Warning letters
- 0
First inspected June 16, 2010. Last inspected December 7, 2023.
Most cited issue areas
- Lack of or inadequate procedures3 inspections
- Calibration, Inspection, etc. Procedures Lack of or Inadequ2 inspections
- Lack of or inadequate complaint procedures2 inspections
FDA inspections (5)
| Date | Result | FDA center(s) | Insp. # |
|---|---|---|---|
| December 7, 2023 | NAI | Medical Devices & Rad Health · Compliance: Devices | 1231425 |
| October 10, 2019 | VAI | Medical Devices & Rad Health · Compliance: Devices | 1106812 |
| September 8, 2016 | VAI | Medical Devices & Rad Health · Compliance: Devices | 987960 |
| April 10, 2013 | VAI | Medical Devices & Rad Health · Compliance: Devices | 827295 |
| June 16, 2010 | VAI | Medical Devices & Rad Health · Compliance: Devices | 667070 |
FDA documents
Form 483s (1)
People (1)
Related Companies (10)
Companies with similar regulatory profiles, compliance history, and operations.
Company Information
Name
International Sterilization Laboratory, LLC
FEI Number
3000203000
Address
217 Sampey Rd, Groveland, Florida 34736, United States
Country
United States
ID: c52ef7fb-6666-4799-814c-e88c40fa2c21