FDA Inspection
Biologische Heilmittel Heel GmbhBiologische Heilmittel Heel Gmbh – FDA Inspection, Feb 1, 2019
Record Details
This FDA Inspection record concerns Biologische Heilmittel Heel Gmbh, with an inspection on February 1, 2019, issued by the Center for Drug Evaluation and Research, covering drugs.
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ID · fdb9887d-a22c-46fc-98d3-24ba38fe3fc2
Inspection Facts
Voluntary Action Indicated (VAI)
Objectionable conditions were found, but FDA is not prepared to take or recommend regulatory action.
- Inspection number
- 1077837
- FDA center
- Human Drugs
- Project area
- Drug Quality Assurance
- Outcome
- Form 483 issued
FDA Citations
7- 21 CFR 211.188Prepared for each batch, include complete information
- 21 CFR 211.160(a)Following/documenting laboratory controls
- 21 CFR 211.176Failing to test for penicillin cross-contamination
- 21 CFR 211.165(a)Testing and release for distribution
- 21 CFR 211.160(a)Lab controls established, including changes
- 21 CFR 211.192Investigations of discrepancies, failures
- 21 CFR 211.22(d)Procedures not in writing, fully followed
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Other FDA inspections of Biologische Heilmittel Heel Gmbh
4| Date | Classification | Office | Project area |
|---|---|---|---|
| April 26, 2023 | VAI | Center for Drug Evaluation and Research | Drug Quality Assurance |
| May 3, 2016 | VAI | Center for Drug Evaluation and Research | Drug Quality Assurance |
| October 31, 2012 | OAI | Center for Drug Evaluation and Research | Drug Quality Assurance |
| July 22, 2010 | NAI | Center for Drug Evaluation and Research | Drug Quality Assurance |
Other documents for Biologische Heilmittel Heel Gmbh
- FDA Inspection 1241139 - 2023-04-26
- FDA Inspection 976690 - 2016-05-03
- FDA Inspection 808745 - 2012-10-31
- FDA Inspection 677561 - 2010-07-22
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