Company
GermanyLTS Lohmann Therapie-Systeme AG, Andernach, Germany – FDA Inspections
Inspection records and compliance data for LTS Lohmann Therapie-Systeme AG in Andernach. 6 FDA inspections on record, 1 Form 483, last inspected May 18, 2022.
Company Profile
This profile covers LTS Lohmann Therapie-Systeme AG based in Andernach, Germany.
FDA Inspection History
- FDA inspections
- 6
- OAI
- 0
- VAI
- 3
- NAI
- 3
- Form 483s
- 1
- Warning letters
- 0
First inspected June 18, 2009. Last inspected May 18, 2022.
Most cited issue areas
- Computer control of master formula records1 inspection
- Establishment of calibration procedures1 inspection
- Scientifically sound laboratory controls1 inspection
FDA inspections (6)
| Date | Result | FDA center(s) | Insp. # |
|---|---|---|---|
| May 18, 2022 | NAI | Human Drugs · Drug Quality Assurance | 1264907 |
| October 31, 2019 | VAI | Human Drugs · Drug Quality Assurance | 1116639 |
| September 15, 2017 | VAI | Human Drugs · Drug Quality Assurance | 1025276 |
| December 20, 2013 | NAI | Human Drugs · Drug Quality Assurance | 865616 |
| June 21, 2011 | VAI | Human Drugs · Drug Quality Assurance | 735498 |
| June 18, 2009 | NAI | Human Drugs · Drug Quality Assurance | 605480 |
FDA documents
No Form 483s, Warning Letters or EIRs on record.
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Company Information
Name
LTS Lohmann Therapie-Systeme AG
FEI Number
3003387535
Address
Lohmannstr. 2, Andernach, Germany
Country
Germany
ID: 1e4dd7e1-b6cb-4ea4-bbfe-fd53318a5151