The compliance record your quality team needs to qualify us.

ACTA is FDA-registered, DEA-licensed across Schedules I to V, and cGMP compliant, with a 35+ year FDA inspection history. Every credential, registration, and quality system is listed on this page.

FDA Registered
DEA Licensed I to V
cGMP
Since 1990
FDA INSPECTION HISTORY

35+ years of FDA inspections.

14FDA inspections, across NDA, ANDA, and general cGMP programs
2Minor observations at the most recent inspection
Sept 2026Most recent FDA inspection

ACTA has been inspected by the FDA since 1990 across new drug applications, abbreviated new drug applications, and general cGMP programs. The most recent inspection was in September 2026 and resulted in 2 minor observations.

REGISTRATIONS & COMPLIANCE

Registrations, scope, and quality systems

FDA Establishment RegistrationRegistered · FEI No. 1000125694
DEA LicenseSchedules I to V · License No. RA0256239
Quality SystemcGMP, 21 CFR Parts 210, 211, and 820
Data Integrity21 CFR Part 11 Computer Systems coupled with Good Documentation Practices
CompendiaUSP, BP, JP, and EP methods
FDA Inspection History14 inspections (NDA, ANDA, and general cGMP) · Most recent Sept. 2026, 2 minor observations
HPLC DetectorsSeven detector types · UV-VIS, PDA, ECD, Conductivity, Fluorescence, ELSD, CAD
Certificate of AnalysisConcise 1 to 2 page cGMP Certificate of Analysis (COA)
Established1990 · 13,000 sq ft, two buildings · Foothill Ranch, CA
ScopePharmaceutical and medical device, FDA-regulated only
Typical Quote Turnaround1 working day
QUALITY SYSTEMS

How the work stays audit-ready.

ACTA operates under current Good Manufacturing Practice, 21 CFR Parts 210, 211, and 820. Analytical data is managed under 21 CFR Part 11 Computer Systems coupled with Good Documentation Practices, so every result is traceable and defensible.

Methods follow USP, BP, JP, CP, and EP compendia, or are developed at ACTA. Method Validation, Transfer, and Verification must be requested by ACTA's client and are required for full cGMP compliance. Controlled-substance work is handled under ACTA's DEA license across Schedules I to V. Every project closes with a concise cGMP Certificate of Analysis, with raw data available on request.

Need our full compliance record or licensing documents?

Our FDA registration, DEA license, and cGMP records are available on request. Reach out and we will send them.

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Qualifying a new lab?

Send us the test and the material. We will scope it, quote it, and a scientist will follow up. FDA-registered, DEA-licensed, cGMP since 1990.
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949-595-0641
info@actalabs.com