Drug factory · FDA FEI 1000125694

ACTA Laboratories Inc

27082 Burbank Street, Foothill Ranch, CA, United States

Problems found, fixed voluntarily at FDA's last inspection, Sep 4, 2026.

Voluntary Action Indicated: inspectors found problems, but not serious enough for FDA to take action. The company is expected to fix them.

7 drug inspections on record since 2009: 2 with no problems, 5 with problems fixed voluntarily, 0 with FDA action.

What it does, for whom

Drug	Role	For	NDC
Morphine	Tests it	Nortec Development Associates, Inc.	42689-005, 42689-006, 42689-007 +3

Ended	Result	Program	Problems noted
Sep 4, 2026	Problems found, fixed voluntarily	Drug Quality Assurance	2
Feb 13, 2023	Problems found, fixed voluntarily	Drug Quality Assurance	3
Jan 19, 2018	Problems found, fixed voluntarily	Drug Quality Assurance	—
Sep 11, 2014	No problems found	Drug Quality Assurance	—
Dec 14, 2011	No problems found	Drug Quality Assurance	—
Sep 30, 2010	Problems found, fixed voluntarily	Drug Quality Assurance	4
Sep 4, 2009	Problems found, fixed voluntarily	Drug Quality Assurance	—

From FDA's Form 483 citations: conditions an investigator observed that may violate drug manufacturing rules, as FDA published them.

Calibration - at intervals, written program, remedial action 21 CFR 211.160(b)(4)
The calibration of apparatus and recording devices is not done at suitable intervals in accordance with an established written program.
Written record of investigation incomplete 21 CFR 211.192
Written records of investigations into unexplained discrepancies and the failure of a batch or any of its components to meet specifications do not always include the conclusions and follow-up.

Procedures not in writing, fully followed 21 CFR 211.22(d)
The responsibilities and procedures applicable to the quality control unit are not in writing and fully followed.
GMP Training Frequency 21 CFR 211.25(a)
GMP training is not conducted on a continuing basis to assure that employees remain familiar with CGMP requirements applicable to them.
Written sanitation procedures not followed 21 CFR 211.56(b)
Written procedures for sanitation are not followed.

Complete test data included in records 21 CFR 211.194(a)
Laboratory records do not include complete data derived from all tests, examinations and assay necessary to assure compliance with established specifications and standards.
Testing and standardization of standards et. al. 21 CFR 211.194(c)
Laboratory records do not include complete records of any testing and standardization of laboratory reference standards, reagents, and standard solutions.
Complaint Handling Procedure 21 CFR 211.198(a)
Procedures describing the handling of written and oral complaints related to drug products are not written or followed.
Backup data not assured as exact and complete 21 CFR 211.68(b)
Backup data is not assured as exact, complete, and secure from alteration, erasure or loss through keeping hard copy or alternate systems.

Registered with FDA for: analysis.