Company
United StatesBi-Coastal Pharma International, Shrewsbury, NJ – FDA Inspections
Inspection records and compliance data for Bi-Coastal Pharma International in Shrewsbury, New Jersey. 2 FDA inspections on record (1 OAI), 1 warning letter, last inspected January 14, 2022.
Company Profile
This profile covers Bi-Coastal Pharma International based in Shrewsbury, New Jersey, United States.
FDA Inspection History
- FDA inspections
- 2
- OAI
- 1
- VAI
- 1
- NAI
- 0
- Form 483s
- 0
- Warning letters
- 1
First inspected September 14, 2020. Last inspected January 14, 2022.
Most cited issue areas
- Complaint Handling Procedure1 inspection
- Complaint Investigation/Follow-Up Findings1 inspection
- Failure to develop written procedures1 inspection
FDA inspections (2)
| Date | Result | FDA center(s) | Insp. # |
|---|---|---|---|
| January 14, 2022 | OAI | Human Drugs · Drug Quality Assurance | 1161078 |
| September 14, 2020 | VAI | Human Drugs · Bioresearch Monitoring | 1129470 |
FDA documents
Warning Letters (1)
Related Companies (10)
Companies with similar regulatory profiles, compliance history, and operations.
Company Information
Name
Bi-Coastal Pharma International
FEI Number
3013263547
Address
1161 Broad St Ste 216, Shrewsbury, New Jersey 07702, United States
Country
United States
ID: 38b9fd58-5145-4f23-9c94-1ba900477ef2