Drug factory · FDA FEI 3002323490

Quality Chemical Laboratories

3400 Enterprise Drive, Wilmington, NC, United States

Problems found, fixed voluntarily at FDA's last inspection, Nov 20, 2024.

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: 1 with no problems, 4 with problems fixed voluntarily, 0 with FDA action.

What it does, for whom

Drug	Role	For	NDC
Amifampridine	Tests it	Catalyst Pharmaceuticals, Inc.	69616-211
Eflornithine	Tests it	Uswm, LLC	78670-150
Ensifentrine	Tests it	Merck Sharp & Dohme LLC	83034-003
Irinotecan	Tests it	Ipsen Biopharmaceuticals, Inc.	15054-0043
Methadone	Tests it	Breckenridge Pharmaceutical, Inc.	51991-002
Naloxone	Tests it	Uswm, LLC	78670-140
Oxcarbazepine	Tests it	Ajanta Pharma USA Inc.	27241-304, 27241-305, 27241-306

Ended	Result	Program	Problems noted
Nov 20, 2024	Problems found, fixed voluntarily	Drug Quality Assurance	2
Jul 27, 2017	Problems found, fixed voluntarily	Drug Quality Assurance	2
Sep 26, 2013	Problems found, fixed voluntarily	Drug Quality Assurance	3
Aug 24, 2010	Problems found, fixed voluntarily	Drug Quality Assurance	3
Apr 1, 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 the failure of a batch or any of its components to meet specifications do not include the conclusions and follow-up.
Equipment Design, Size and Location 21 CFR 211.63
Equipment used in the manufacture, processing, packing or holding of drug products is not of appropriate design to facilitate operations for its intended use.

SOPs not followed / documented 21 CFR 211.100(b)
Written production and process control procedures are not documented at the time of performance.
Procedures not in writing, fully followed 21 CFR 211.22(d)
The responsibilities and procedures applicable to the quality control unit are not fully followed.

Following/documenting laboratory controls 21 CFR 211.160(a)
Established test procedures are not followed.
Lab controls established, including changes 21 CFR 211.160(a)
The establishment of test procedures including any changes thereto, are not drafted by the appropriate organizational unit and reviewed and approved by the quality control unit.
Test methods 21 CFR 211.165(e)
The accuracy and reproducibility of test methods have not been established.

Following/documenting laboratory controls 21 CFR 211.160(a)
Established test procedures are not followed.
Test methods 21 CFR 211.165(e)
The accuracy, sensitivity, specificity, and reproducibility of test methods have not been established and documented.
Laboratory equipment calibration records 21 CFR 211.194(d)
Laboratory records do not include complete records of the periodic calibration of laboratory instruments.

Registered with FDA for: analysis; api manufacture; manufacture; pack.