Drug factory · FDA FEI 3008255368

Solupharm Pharmazeutische Erzeugnisse GmbH

Industriestraße 3, Melsungen, Germany

Problems found, fixed voluntarily at FDA's last inspection, Jul 29, 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 2011: 1 with no problems, 4 with problems fixed voluntarily, 0 with FDA action.

What it does, for whom

Drug	Role	For	NDC
Acetaminophen	Makes it	Solupharm Pharmazeutische Erzeugnisse GmbH	55579-110, 55579-405
Sugammadex	Makes it, tests it, packages it, labels it and sterilizes it	Solupharm Pharmazeutische Erzeugnisse GmbH, Somerset Therapeutics, LLC	55579-892, 55579-893, 70069-892 +1

Ended	Result	Program	Problems noted
Jul 29, 2022	Problems found, fixed voluntarily	Drug Quality Assurance	—
Feb 2, 2018	Problems found, fixed voluntarily	Drug Quality Assurance	3
Jun 21, 2016	Problems found, fixed voluntarily	Drug Quality Assurance	—
Sep 22, 2014	Problems found, fixed voluntarily	Drug Quality Assurance	4
Nov 22, 2011	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.

Manufacturing Instructions and Specifications 21 CFR 211.186(b)(9)
The master production and control records are deficient in that they do not include complete control and instructions.
Complete Test Data 21 CFR 211.194(a)(4)
Laboratory records are deficient in that they do not include a complete record of all data obtained during testing.
Clothing appropriate for duties performed 21 CFR 211.28(a)
Clothing of personnel engaged in the manufacturing and processing of drug products is not appropriate for the duties they perform.

Deviations of production time limits 21 CFR 211.111
Deviations from production time limits are not justified.
Scientifically sound laboratory controls 21 CFR 211.160(b)
Laboratory controls do not include the establishment of scientifically sound and appropriate test procedures designed to assure that in-process materials and drug products conform to appropriate standards of identity, strength, quality and purity.
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.
Environmental Monitoring System 21 CFR 211.42(c)(10)(iv)
Aseptic processing areas are deficient regarding the system for monitoring environmental conditions.

Registered with FDA for: analysis; label; manufacture; pack; sterilize.