Drug factory · FDA FEI 3002808845
Rommelag CDMO GmbH
Bahnhofstr. 18, Sulzbach-Laufen, Germany
Problems found, fixed voluntarily at FDA's last inspection, Mar 20, 2025.
Voluntary Action Indicated: inspectors found problems, but not serious enough for FDA to take action. The company is expected to fix them.
8 drug inspections on record since 2012: 2 with no problems, 6 with problems fixed voluntarily, 0 with FDA action.
What it does, for whom
| Drug | Role | For | NDC |
|---|---|---|---|
| Arformoterol | Makes it | Alembic Pharmaceuticals Inc. | 62332-633 |
| Ciprofloxacin | Makes it | Alembic Pharmaceuticals Inc. | 62332-168 |
| Formoterol | Makes it | Alembic Pharmaceuticals Inc. | 62332-655 |
| Ropivacaine | Makes it | BioQ Pharma Incorporated | 71807-011 |
| Timolol | Makes it, packages it and labels it | Armas Pharmaceuticals Inc., Nordic Pharma, Inc. | 72485-602, 69918-601 |
| Tobramycin | Makes it and packages it | Ascend Laboratories, LLC, Dr. Reddy's Laboratories Inc., Northstar Rx LLC. | 67877-678, 43598-605, 16714-119 |
FDA inspection history
| Ended | Result | Program | Problems noted |
|---|---|---|---|
| Mar 20, 2025 | Problems found, fixed voluntarily | Drug Quality Assurance | — |
| Apr 5, 2022 | Problems found, fixed voluntarily | Drug Quality Assurance | — |
| Sep 17, 2019 | No problems found | Drug Quality Assurance | — |
| Oct 22, 2015 | Problems found, fixed voluntarily | Drug Quality Assurance | — |
| Feb 14, 2014 | Problems found, fixed voluntarily | Drug Quality Assurance | — |
| Feb 12, 2014 | Problems found, fixed voluntarily | Drug Quality Assurance | — |
| Feb 24, 2012 | Problems found, fixed voluntarily | Drug Quality Assurance | — |
| Feb 17, 2012 | No problems found | Drug Quality Assurance | — |
Registered with FDA for: analysis; label; manufacture; pack.