FDA Inspection
Odan Laboratories LtdOdan Laboratories Ltd – FDA Inspection, Dec 15, 2017
Record Details
This FDA Inspection record concerns Odan Laboratories Ltd, with an inspection on December 15, 2017, issued by the Center for Drug Evaluation and Research, covering drugs.
View Company Profile
ID · c11d9882-dc0b-4b38-aa78-09280cfb31d7
Inspection Facts
Voluntary Action Indicated (VAI)
Objectionable conditions were found, but FDA is not prepared to take or recommend regulatory action.
- Inspection number
- 1035031
- FDA center
- Human Drugs
- Project area
- Drug Quality Assurance
- Outcome
- Form 483 issued
FDA Citations
5- 21 CFR 211.63Equipment Design, Size and Location
- 21 CFR 211.166(a)Results not used for expiration dates, storage cond.
- 21 CFR 211.48(a)Plumbing System Defects
- 21 CFR 211.192Investigations of discrepancies, failures
- 21 CFR 211.22(d)Procedures not in writing, fully followed
Full citation text and observation details available on the Dashboard.
Other FDA inspections of Odan Laboratories Ltd
2| Date | Classification | Office | Project area |
|---|---|---|---|
| February 20, 2020 | VAI | Center for Drug Evaluation and Research | Drug Quality Assurance |
| March 18, 2016 | VAI | Center for Drug Evaluation and Research | Drug Quality Assurance |
Other documents for Odan Laboratories Ltd
- FDA Inspection 1118442 - 2020-02-20
- FDA Inspection 967736 - 2016-03-18
Document or profile
One record shows the event. A profile shows the pattern.
Buy this document for the source file and details behind this single event.
Choose full profile access to connect related records, sites, people, citations, and enforcement history in one view.