Drug factory · FDA FEI 2219935

New Jersey Laboratories

1110 Somerset St., New Brunswick, NJ, United States

Problems found, fixed voluntarily at FDA's last inspection, Sep 22, 2022.

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

5 drug inspections on record since 2010: 2 with no problems, 3 with problems fixed voluntarily, 0 with FDA action.

What it does, for whom

Drug	Role	For	NDC
Desmopressin	Tests it	Eton Pharmaceuticals, Inc.	71863-123
Hydrocortisone	Tests it	Eton Pharmaceuticals, Inc.	71863-116

Ended	Result	Program	Problems noted
Sep 22, 2022	Problems found, fixed voluntarily	Drug Quality Assurance	1
Sep 23, 2016	Problems found, fixed voluntarily	Drug Quality Assurance	4
Jul 9, 2014	No problems found	Drug Quality Assurance	—
Jun 29, 2012	Problems found, fixed voluntarily	Drug Quality Assurance	—
Apr 9, 2010	No problems found	Drug Quality Assurance	—

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

Written record of investigation incomplete 21 CFR 211.192
Written records of investigations into unexplained discrepancies do not always include the conclusions and follow-up.

Following/documenting laboratory controls 21 CFR 211.160(a)
Established laboratory control mechanisms are not followed.
Establishment of calibration procedures 21 CFR 211.160(b)(4)
Procedures describing the calibration of instruments, apparatus, gauges and recording devices are deficiently written or followed.
Test methods 21 CFR 211.165(e)
The accuracy and reproducibility of test methods have not been established and documented.
Investigations of discrepancies, failures 21 CFR 211.192
There is a failure to thoroughly review any unexplained discrepancy whether or not the batch has been already distributed.

Registered with FDA for: analysis.