Drug factory · FDA FEI 3009075542
ROTOP Pharmaka GmbH
Bautzner Landstrasse 400, Dresden, Germany
Problems found, fixed voluntarily at FDA's last inspection, Jul 2, 2021.
Voluntary Action Indicated: inspectors found problems, but not serious enough for FDA to take action. The company is expected to fix them.
2 drug inspections on record since 2018: 0 with no problems, 2 with problems fixed voluntarily, 0 with FDA action.
What it does, for whom
| Drug | Role | For | NDC |
|---|---|---|---|
| 2,3-Dimercaptosuccinic Acid | Makes it | ROTOP Pharmaka GmbH | 71647-001 |
| Succimer | Makes it, makes the active ingredient, tests it, packages it and labels it | Theragnostics Inc | 71083-0020 |
FDA inspection history
| Ended | Result | Program | Problems noted |
|---|---|---|---|
| Jul 2, 2021 | Problems found, fixed voluntarily | Drug Quality Assurance | — |
| Dec 7, 2018 | Problems found, fixed voluntarily | Drug Quality Assurance | 5 |
What inspectors wrote down
From FDA's Form 483 citations: conditions an investigator observed that may violate drug manufacturing rules, as FDA published them.
Dec 7, 2018 inspection
- Annual visual exams of drug products 21 CFR 211.170(b)
Reserve samples from representative sample lots or batches of drug products selected by acceptable statistical procedures are not examined visually at least once a year for evidence of deterioration. - Suitability of testing methods verified 21 CFR 211.194(a)(2)
The suitability of all testing methods is not verified under actual conditions of use. - Second person sign off 21 CFR 211.194(a)(8)
Laboratory records do not include the initials or signature of a second person showing that the original records have been reviewed for accuracy, completeness and compliance with established standards. - GMP Training Frequency 21 CFR 211.25(a)
GMP training is not conducted on a continuing basis and with sufficient frequency to assure that employees remain familiar with CGMP requirements applicable to them. - Testing Each Component for Conformity with Specs 21 CFR 211.84(d)(2)
Each component is not tested for conformity with all appropriate written specifications for purity, strength, and quality.
Registered with FDA for: analysis; api manufacture; label; manufacture; pack.