FDA Inspection
Crown Laboratories IncCrown Laboratories Inc – FDA Inspection, Apr 8, 2016
Record Details
This FDA Inspection record concerns Crown Laboratories Inc, with an inspection on April 8, 2016, issued by the Center for Drug Evaluation and Research, covering drugs.
- Company
- Crown Laboratories Inc
- Inspection Date
- April 8, 2016
- Product Type
- Drugs
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ID · b6b3dc9c-ce5b-47d6-b61a-e3d309d3179f
Inspection Facts
Voluntary Action Indicated (VAI)
Objectionable conditions were found, but FDA is not prepared to take or recommend regulatory action.
- Inspection number
- 973822
- FDA center
- Human Drugs
- Project area
- Bioresearch Monitoring
FDA Citations
5- 21 CFR 310.305(c)(1)(i)Late submission
- 21 CFR 11Electronic records
- 21 CFR 211.194(a)(4)Data secured in course of each test
- 21 CFR 211.198(a)Complaint Handling Procedure
- Failure of responsible person to report AE (non-RX Drug)
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Other FDA inspections of Crown Laboratories Inc
7| Date | Classification | Office | Project area |
|---|---|---|---|
| September 19, 2025 | VAI | New Orleans District Office | Drug Quality Assurance |
| March 15, 2018 | NAI | Center for Drug Evaluation and Research | Drug Quality Assurance |
| February 15, 2018 | NAI | Center for Drug Evaluation and Research | Bioresearch Monitoring |
| September 24, 2014 | OAI | Center for Drug Evaluation and Research | Unapproved and Misbranded Drugs |
| February 14, 2014 | OAI | Center for Drug Evaluation and Research | Unapproved and Misbranded Drugs |
Other documents for Crown Laboratories Inc
- FDA Inspection 1254956 - 2025-09-19
- FDA Inspection 1050586 - 2018-03-15
- FDA Inspection 1045454 - 2018-02-15
- FDA Inspection 898298 - 2014-09-24
- FDA Inspection 866595 - 2014-02-14
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