FDA Inspection
BiocodexBiocodex – FDA Inspection, May 25, 2018
Record Details
This FDA Inspection record concerns Biocodex, with an inspection on May 25, 2018, issued by the Office of Inspections and Investigations, covering human drugs.
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ID · 4f41d61d-6ab3-483d-8c92-386fdbbb0172
Inspection Facts
Voluntary Action Indicated (VAI)
Objectionable conditions were found, but FDA is not prepared to take or recommend regulatory action.
- Inspection number
- 1053229
- FDA center
- Human Drugs
- Project area
- New Drug Evaluation
- Outcome
- Form 483 issued
FDA Citations
4- 21 CFR 211.160(b)Scientifically sound laboratory controls
- 21 CFR 211.192Investigations of discrepancies, failures
- 21 CFR 211.194(a)Complete test data included in records
- 21 CFR 211.22(d)Procedures not in writing, fully followed
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Other FDA inspections of Biocodex
4| Date | Classification | Office | Project area |
|---|---|---|---|
| June 17, 2022 | VAI | Center for Drug Evaluation and Research | Drug Quality Assurance |
| January 23, 2020 | VAI | Center for Drug Evaluation and Research | Drug Quality Assurance |
| October 20, 2016 | Not classified | Office of Inspections and Investigations | |
| September 16, 2016 | NAI | Center for Drug Evaluation and Research | Bioresearch Monitoring |
Other documents for Biocodex
- FDA Inspection 1283742 - 2022-06-17
- FDA Inspection 1135732 - 2020-01-23
- FDA Inspection 992497 - 2016-10-20
- FDA Inspection 986993 - 2016-09-16
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