FDA Inspection
Avara Pharmaceutical Technologies, Inc.Avara Pharmaceutical Technologies, Inc. – FDA Inspection, Sep 26, 2018
Record Details
This FDA Inspection record concerns Avara Pharmaceutical Technologies, Inc., with an inspection on September 26, 2018, issued by the Center for Drug Evaluation and Research, covering drugs.
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ID · 29f4473c-c275-40ce-a917-6b0c5fbe4f4d
Inspection Facts
Voluntary Action Indicated (VAI)
Objectionable conditions were found, but FDA is not prepared to take or recommend regulatory action.
- Inspection number
- 1066751
- FDA center
- Human Drugs
- Project area
- Drug Quality Assurance
- Outcome
- Form 483 issued
FDA Citations
4- 21 CFR 211.100(b)Procedure Deviations Recorded and Justified
- 21 CFR 211.113(a)Procedures for non-sterile drug products
- 21 CFR 211.80(a)Procedures To Be in Writing
- 21 CFR 211.100(b)SOPs not followed / documented
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Other FDA inspections of Avara Pharmaceutical Technologies, Inc.
4| Date | Classification | Office | Project area |
|---|---|---|---|
| June 2, 2026 | Not classified | Dallas District Office | |
| October 31, 2022 | NAI | Center for Drug Evaluation and Research | Drug Quality Assurance |
| March 30, 2012 | NAI | Center for Drug Evaluation and Research | Drug Quality Assurance |
| September 27, 2010 | NAI | Center for Drug Evaluation and Research | Drug Quality Assurance |
Other documents for Avara Pharmaceutical Technologies, Inc.
- FDA Inspection 1322324 - 2026-06-02
- FDA Inspection 1192124 - 2022-10-31
- FDA Inspection 773884 - 2012-03-30
- FDA Inspection 683863 - 2010-09-27
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