Drug factory · FDA FEI 3003387535
LTS Lohmann Therapie-Systeme AG
Lohmann Strasse 2, Andernach, Germany
No problems found at FDA's last inspection, May 18, 2022.
No Action Indicated: inspectors found no objectionable conditions.
6 drug inspections on record since 2009: 3 with no problems, 3 with problems fixed voluntarily, 0 with FDA action.
What it does, for whom
| Drug | Role | For | NDC |
|---|---|---|---|
| Buprenorphine | Makes it | Rhodes Pharmaceuticals L.P. | 42858-353, 42858-493, 42858-586 +2 |
| Capsaicin | Makes it | Averitas Pharma, Inc. | 72512-928, 72512-929, 72512-930 |
| Scopolamine | Makes it | Rhodes Pharmaceuticals L.P. | 42858-150 |
FDA inspection history
| Ended | Result | Program | Problems noted |
|---|---|---|---|
| May 18, 2022 | No problems found | Drug Quality Assurance | — |
| Oct 31, 2019 | Problems found, fixed voluntarily | Drug Quality Assurance | — |
| Sep 15, 2017 | Problems found, fixed voluntarily | Drug Quality Assurance | 3 |
| Dec 20, 2013 | No problems found | Drug Quality Assurance | — |
| Jun 21, 2011 | Problems found, fixed voluntarily | Drug Quality Assurance | — |
| Jun 18, 2009 | No problems found | Drug Quality Assurance | — |
What inspectors wrote down
From FDA's Form 483 citations: conditions an investigator observed that may violate drug manufacturing rules, as FDA published them.
Sep 15, 2017 inspection
- 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 conform to appropriate standards of identity, strength, quality and purity. - Establishment of calibration procedures 21 CFR 211.160(b)(4)
Procedures describing the calibration of instruments, apparatus, gauges and recording devices are not written or followed. - Computer control of master formula records 21 CFR 211.68(b)
Appropriate controls are not exercised over computers or related systems to assure that changes in master production and control records or other records are instituted only by authorized personnel.
Registered with FDA for: analysis; manufacture; pack.