Company
United StatesWinchester Laboratories, LLC, Delray Beach, FL – FDA Inspections
Inspection records and compliance data for Winchester Laboratories, LLC in Delray Beach, Florida. 2 FDA inspections on record, 1 Form 483, last inspected June 13, 2017.
Company Profile
This profile covers Winchester Laboratories, LLC based in Delray Beach, Florida, United States.
FDA Inspection History
- FDA inspections
- 2
- OAI
- 0
- VAI
- 1
- NAI
- 1
- Form 483s
- 1
- Warning letters
- 0
First inspected March 12, 2012. Last inspected June 13, 2017.
Most cited issue areas
- Design control - no procedures1 inspection
- DMR - not or inadequately maintained1 inspection
- Lack of or inadequate procedures1 inspection
FDA inspections (2)
| Date | Result | FDA center(s) | Insp. # |
|---|---|---|---|
| June 13, 2017 | VAI | Medical Devices & Rad Health · Compliance: Devices | 1014220 |
| March 12, 2012 | NAI | Human Drugs, Medical Devices & Rad Health · Compliance: Devices | 774373 |
FDA documents
No Form 483s, Warning Letters or EIRs on record.
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Company Information
Name
Winchester Laboratories, LLC
FEI Number
3003036307
Address
301 W Atlantic Ave Ste 1, Delray Beach, Florida 33444, United States
Country
United States
ID: 27080acb-b665-4425-806f-d68d317a1f2f