Drug factory · FDA FEI 1379

Dynamit Nobel GmbH Explosivstoff- und Systemtechnik

Kalkstr. 218, Leverkusen, Germany

Problems found, fixed voluntarily at FDA's last inspection, Sep 1, 2023.

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 2009: 2 with no problems, 3 with problems fixed voluntarily, 0 with FDA action.

What it does, for whom

Drug	Role	For	NDC
Gadolinium Cation (3+)	Makes the active ingredient	Bayer HealthCare Pharmaceuticals Inc.	50419-325
Nitroglycerin	Makes it and makes the active ingredient	Rouses Point Pharm	43478-410
Oteseconazole	Makes the active ingredient	Mycovia Pharmaceuticals, Inc.	74695-823

Ended	Result	Program	Problems noted
Sep 1, 2023	Problems found, fixed voluntarily	Drug Quality Assurance	—
Dec 7, 2018	Problems found, fixed voluntarily	Drug Quality Assurance	3
May 6, 2016	No problems found	Drug Quality Assurance	—
Jul 18, 2013	Problems found, fixed voluntarily	Drug Quality Assurance	—
May 22, 2009	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.

Investigations of discrepancies, failures 21 CFR 211.192
There is a failure to thoroughly review any unexplained discrepancy and the failure of a batch or any of its components to meet any of its specifications whether or not the batch has been already distributed.
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.
Written procedures fail to include 21 CFR 211.67(b)
Written procedures for cleaning and maintenance fail to include parameters relevant to the operation.

Registered with FDA for: analysis; api manufacture.