Company
RomaniaSindan-Pharma SRL, Bucharest, Romania – FDA Inspections
Inspection records and compliance data for Sindan-Pharma SRL in Bucharest. 7 FDA inspections on record, 1 Form 483, last inspected August 02, 2024.
Company Profile
This profile covers Sindan-Pharma SRL based in Bucharest, Romania.
FDA Inspection History
- FDA inspections
- 7
- OAI
- 0
- VAI
- 2
- NAI
- 4
- Unclassified
- 1
- Form 483s
- 1
- Warning letters
- 0
First inspected April 6, 2011. Last inspected August 2, 2024.
Most cited issue areas
- Absence of Written Procedures1 inspection
- Acceptance criteria for sampling & testing1 inspection
- Cleaning / Sanitizing / Maintenance1 inspection
FDA inspections (7)
| Date | Result | FDA center(s) | Insp. # |
|---|---|---|---|
| August 2, 2024 | NAI | Human Drugs · Bioresearch Monitoring | 1247794 |
| March 16, 2023 | Not classified | Human Drugs | 1244074 |
| April 5, 2018 | VAI | Human Drugs · Drug Quality Assurance | 1137635 |
| July 28, 2017 | VAI | Human Drugs · Drug Quality Assurance | 1019456 |
| June 15, 2015 | NAI | Human Drugs · Drug Quality Assurance | 933708 |
| December 10, 2013 | NAI | Human Drugs · Drug Quality Assurance | 874880 |
| April 6, 2011 | NAI | Human Drugs · Drug Quality Assurance | 720234 |
FDA documents
No Form 483s, Warning Letters or EIRs on record.
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Company Information
Name
Sindan-Pharma SRL
FEI Number
3005566806
Address
179-185 Odai Street, Bucharest, Romania
Country
Romania
ID: a5d5942e-c682-491a-9b60-29ef1cf6a5ee