FDA Inspection
LTS Lohmann Therapie-Systeme AGLTS Lohmann Therapie-Systeme AG – FDA Inspection, Sep 15, 2017
Record Details
This FDA Inspection record concerns LTS Lohmann Therapie-Systeme AG, with an inspection on September 15, 2017, issued by the Center for Drug Evaluation and Research, covering drugs.
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ID · c1987bd1-1c89-40bd-bd34-a41203873a0c
Inspection Facts
Voluntary Action Indicated (VAI)
Objectionable conditions were found, but FDA is not prepared to take or recommend regulatory action.
- Inspection number
- 1025276
- FDA center
- Human Drugs
- Project area
- Drug Quality Assurance
- Outcome
- Form 483 issued
FDA Citations
3- 21 CFR 211.68(b)Computer control of master formula records
- 21 CFR 211.160(b)Scientifically sound laboratory controls
- 21 CFR 211.160(b)(4)Establishment of calibration procedures
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Other FDA inspections of LTS Lohmann Therapie-Systeme AG
5| Date | Classification | Office | Project area |
|---|---|---|---|
| May 18, 2022 | NAI | Center for Drug Evaluation and Research | Drug Quality Assurance |
| October 31, 2019 | VAI | Center for Drug Evaluation and Research | Drug Quality Assurance |
| December 20, 2013 | NAI | Center for Drug Evaluation and Research | Drug Quality Assurance |
| June 21, 2011 | VAI | Center for Drug Evaluation and Research | Drug Quality Assurance |
| June 18, 2009 | NAI | Center for Drug Evaluation and Research | Drug Quality Assurance |
Other documents for LTS Lohmann Therapie-Systeme AG
- FDA Inspection 1264907 - 2022-05-18
- FDA Inspection 1116639 - 2019-10-31
- FDA Inspection 865616 - 2013-12-20
- FDA Inspection 735498 - 2011-06-21
- FDA Inspection 605480 - 2009-06-18
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