FDA Inspection
Fidelio Healthcare Limburg GmbHFidelio Healthcare Limburg GmbH – FDA Inspection, May 23, 2014
Record Details
This FDA Inspection record concerns Fidelio Healthcare Limburg GmbH, with an inspection on May 23, 2014, issued by the Center for Drug Evaluation and Research, covering drugs.
- Inspection Date
- May 23, 2014
- Product Type
- Drugs
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ID · c818c715-349a-471f-868f-002086e7ec8c
Inspection Facts
Voluntary Action Indicated (VAI)
Objectionable conditions were found, but FDA is not prepared to take or recommend regulatory action.
- Inspection number
- 889394
- FDA center
- Human Drugs
- Project area
- Drug Quality Assurance
FDA Citations
10- 21 CFR 211.170(b)Drug product reserve containers
- 21 CFR 211.101(d)Component addition checked by 2nd person
- 21 CFR 211.160(b)Scientifically sound laboratory controls
- 21 CFR 211.194(a)Complete test data included in records
- 21 CFR 211.194(d)Laboratory equipment calibration records
- 21 CFR 211.170(b)Annual visual exams of drug products
- 21 CFR 211.68(a)Calibration/Inspection/Checking not done
- 21 CFR 211.165(a)Testing and release for distribution
- 21 CFR 211.186(a)Signature and checking of records -- 2 persons
- 21 CFR 211.22(d)Procedures not in writing, fully followed
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Other FDA inspections of Fidelio Healthcare Limburg GmbH
4| Date | Classification | Office | Project area |
|---|---|---|---|
| November 17, 2023 | Not classified | Office of Inspections and Investigations | |
| July 20, 2022 | VAI | Center for Drug Evaluation and Research | Drug Quality Assurance |
| February 2, 2017 | VAI | Center for Drug Evaluation and Research | Drug Quality Assurance |
| September 21, 2011 | NAI | Center for Drug Evaluation and Research | Drug Quality Assurance |
Other documents for Fidelio Healthcare Limburg GmbH
- FDA Inspection 1223517 - 2023-11-17
- FDA Inspection 1234400 - 2022-07-20
- FDA Inspection 999720 - 2017-02-02
- FDA Inspection 748702 - 2011-09-21
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