DPT Laboratories
Quick Facts: DPT Laboratories
- Signal Score
- Profiled, not yet scored. Scores are published after regulatory evidence is attached and reviewed. How scoring works
- Headquarters
- San Antonio, Texas, United States
- Website
- https://www.dptlabs.com/
- Modalities
- Semi-solids & Liquids, Non-sterile Liquids, Topicals, Finished Dosage Forms, Sterile Fill-Finish, Clinical Trial Manufacturing
- Active Programs
- No ClinicalTrials.gov matches confirmed
- Data Sources
- FDA Data Dashboard, ClinicalTrials.gov, SEC EDGAR, press monitoring
About DPT Laboratories
DPT Laboratories is a contract development and manufacturing organization (CDMO). Capabilities: Semi-solids & Liquids, Non-sterile Liquids, Topicals, Finished Dosage Forms, Sterile Fill-Finish, Clinical Trial Manufacturing. 1 manufacturing site registered with the U.S. FDA. Website: https://www.dptlabs.com/
Signal Score
DPT Laboratories FDA Inspection History
| Date | Site | Type | Observations | Classification |
|---|---|---|---|---|
| 2026-02-10 |
DPT Laboratories Ltd
San Antonio, Texas
Company-level
|
Drug Quality Assurance | Yes | Voluntary Action Indicated (VAI) |
| 2025-05-06 |
DPT Laboratories Ltd.
San Antonio, Texas
Facility-linked
|
Drug Quality Assurance | No | No Action Indicated (NAI) |
| 2024-05-29 |
DPT Laboratories, Ltd
San Antonio, Texas
Company-level
|
Drug Quality Assurance | No | No Action Indicated (NAI) |
| 2023-05-05 |
DPT Laboratories, Ltd
San Antonio, Texas
Company-level
|
Drug Quality Assurance | No | No Action Indicated (NAI) |
DPT Laboratories FDA 483 Findings 2 observations · 2026-02-10 → 2026-02-10 ?
By subsystem
By severity
- 2 — Minor: 2
- Repeat observations: 0
Most severe findings
-
Absence of Written Procedures
"Your firm failed to establish adequate written procedures for production and process controls designed to assure that the drug products have the identity, strength, purity, and quality that they are purported or represented to possess."
-
Control procedures to monitor and validate performance
"Control procedures are not established which monitor the output and validate the performance of those manufacturing processes that may be responsible for causing variability in the characteristics of in-process material and the drug product."
DPT Laboratories MHRA GMP Compliance 6 certificates
| Certificate | Site | City / Postcode | Inspection Date | Status |
|---|---|---|---|---|
| UK GMP 14862 Insp GMP 14862/1234563-0004 [H] | DPT LABORATORIES LIMITED | 78235 | 2014-12-08 | COMPLIANT |
| UK GMP 14862 Insp GMP 14862/1234563-0004 [V] | DPT LABORATORIES LIMITED | 78235 | 2014-12-08 | COMPLIANT |
| UK GMP 14862 Insp GMP 14862/1234565-0004 [H] | DPT LABORATORIES LIMITED | 78218 | 2014-12-08 | COMPLIANT |
| UK GMP 14862 Insp GMP 14862/1234565-0004 [V] | DPT LABORATORIES LIMITED | 78218 | 2014-12-08 | COMPLIANT |
| UK GMP 14862 Insp GMP 14862/5729-0006 [H] | DPT LABORATORIES LIMITED | 78215 | 2014-12-08 | COMPLIANT |
| UK GMP 14862 Insp GMP 14862/5729-0006 [V] | DPT LABORATORIES LIMITED | 78215 | 2014-12-08 | COMPLIANT |