Company
IndiaTRUECARE BIOMEDIX - Inspection Records
Inspection records and compliance data for TRUECARE BIOMEDIX in Balasinor. 3 FDA inspections on record, 1 Form 483, last inspected February 21, 2025.
Company Profile
This profile covers TRUECARE BIOMEDIX based in Balasinor, None, India.
FDA Inspection History
- FDA inspections
- 3
- OAI
- 0
- VAI
- 2
- NAI
- 0
- Unclassified
- 1
- Form 483s
- 1
- Warning letters
- 0
First inspected November 3, 2017. Last inspected February 21, 2025.
Most cited issue areas
- Batch production and Batch Control Record Requirements2 inspections
- Annual visual exams of drug products1 inspection
- Backup data not assured as exact and complete1 inspection
Most recent inspections
| Date | Classification | Office | Project area |
|---|---|---|---|
| February 21, 2025 | Not classified | Office of Inspections and Investigations | |
| March 6, 2020 | VAI | Center for Drug Evaluation and Research | Drug Quality Assurance |
| November 3, 2017 | VAI | Center for Drug Evaluation and Research | Drug Quality Assurance |
Documents (6)
483 - TRUECARE BIOMEDIX - 2025-02-21
483
483 - TRUECARE BIOMEDIX - 2025-02-21
483
FDA Inspection 1256916 - TRUECARE BIOMEDIX - 2025-02-21
fda_inspection
FDA Inspection 1256916 - TRUECARE BIOMEDIX - 2025-02-21
fda_inspection
FDA Inspection 1119892 - TRUECARE BIOMEDIX - 2020-03-06
fda_inspection
FDA Inspection 1030939 - TRUECARE BIOMEDIX - 2017-11-03
fda_inspection
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Name
TRUECARE BIOMEDIX
FEI Number
3010166683
State
None
City
Balasinor
ID: 08911ceb-dc17-46dc-bab8-b43b871cc64c