Company
United StatesBioChroma Analytical Labs, LLC., Dallas, TX – FDA Inspections
Inspection records and compliance data for BioChroma Analytical Labs, LLC. in Dallas, Texas. 2 FDA inspections on record, 1 Form 483, last inspected February 23, 2026.
Company Profile
This profile covers BioChroma Analytical Labs, LLC. based in Dallas, Texas, United States.
FDA Inspection History
- FDA inspections
- 2
- OAI
- 0
- VAI
- 1
- NAI
- 0
- Unclassified
- 1
- Form 483s
- 1
- Warning letters
- 0
First inspected February 8, 2017. Last inspected February 23, 2026.
Most cited issue areas
- Calibration/Inspection/Checking not done1 inspection
- Computer control of master formula records1 inspection
- Establishment of calibration procedures1 inspection
FDA inspections (2)
| Date | Result | FDA center(s) | Insp. # |
|---|---|---|---|
| February 23, 2026 | Not classified | Human Drugs | 1305488 |
| February 8, 2017 | VAI | Human Drugs · Drug Quality Assurance | 1009808 |
FDA documents
No Form 483s, Warning Letters or EIRs on record.
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Company Information
Name
BioChroma Analytical Labs, LLC.
FEI Number
3012816120
Address
1309 Record Crossing Rd, Dallas, Texas 75235, United States
Country
United States
ID: 2b070f6f-500c-4a8e-993a-7dc937325978