Company
United StatesBalassa Laboratories, Inc., Port Orange, FL – FDA Inspections
Inspection records and compliance data for Balassa Laboratories, Inc. in Port Orange, Florida. 5 FDA inspections on record (1 OAI), 3 Form 483s, last inspected August 21, 2026.
Company Profile
This profile covers Balassa Laboratories, Inc. based in Port Orange, Florida, United States.
FDA Inspection History
- FDA inspections
- 5
- OAI
- 1
- VAI
- 4
- NAI
- 0
- Form 483s
- 3
- Warning letters
- 0
First inspected February 19, 2013. Last inspected August 21, 2026.
Most cited issue areas
- Annual visual exams of drug products1 inspection
- Approved school1 inspection
- Batch record - complete1 inspection
FDA inspections (5)
| Date | Result | FDA center(s) | Insp. # |
|---|---|---|---|
| August 21, 2026 | VAI | Foods & Cosmetics · Foodborne Biological Hazards | 1332070 |
| April 7, 2023 | VAI | Human Drugs · Drug Quality Assurance | 1202446 |
| April 23, 2018 | VAI | Human Drugs · Drug Quality Assurance | 1049200 |
| April 25, 2014 | VAI | Human Drugs · Drug Quality Assurance | 876075 |
| February 19, 2013 | OAI | Human Drugs · Drug Quality Assurance | 819218 |
FDA documents
Form 483s (1)
People (1)
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Companies with similar regulatory profiles, compliance history, and operations.
Company Information
Name
Balassa Laboratories, Inc.
FEI Number
1050280
Address
511 Herbert Street, Suite A, Port Orange, Florida 32129, United States
Country
United States
ID: 86332abb-f7b6-407f-a65e-3c0ecf3c16fd