FDA Inspection
Alza CorporationAlza Corporation – FDA Inspection, Feb 1, 2018
Record Details
This FDA Inspection record concerns Alza Corporation, with an inspection on February 1, 2018, issued by the Center for Devices and Radiological Health, covering devices.
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ID · ea30a6c6-c924-4074-84da-b9ef6416bef2
Inspection Facts
Voluntary Action Indicated (VAI)
Objectionable conditions were found, but FDA is not prepared to take or recommend regulatory action.
- Inspection number
- 1039728
- FDA center
- Medical Devices & Rad Health
- Project area
- Compliance: Devices
- Outcome
- Form 483 issued
FDA Citations
2- 21 CFR 211.68(b)Computer control of master formula records
- 21 CFR 211.182Written records kept in individual logs
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Other FDA inspections of Alza Corporation
8| Date | Classification | Office | Project area |
|---|---|---|---|
| June 29, 2016 | NAI | Center for Drug Evaluation and Research | Drug Quality Assurance |
| September 19, 2014 | VAI | Center for Drug Evaluation and Research | Drug Quality Assurance |
| March 14, 2014 | VAI | Center for Drug Evaluation and Research | Drug Quality Assurance |
| March 22, 2013 | VAI | Center for Drug Evaluation and Research | Drug Quality Assurance |
| April 12, 2012 | VAI | Center for Drug Evaluation and Research | Drug Quality Assurance |
Other documents for Alza Corporation
- FDA Inspection 982489 - 2016-06-29
- FDA Inspection 897977 - 2014-09-19
- FDA Inspection 870168 - 2014-03-14
- FDA Inspection 829365 - 2013-03-22
- FDA Inspection 777640 - 2012-04-12
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