FDA Inspection
Larken Laboratories, Inc.Larken Laboratories, Inc. – FDA Inspection, Oct 8, 2020
Record Details
This FDA Inspection record concerns Larken Laboratories, Inc., with an inspection on October 8, 2020, issued by the Center for Drug Evaluation and Research, covering drugs.
- Company
- Larken Laboratories, Inc.
- Inspection Date
- October 8, 2020
- Product Type
- Drugs
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ID · 0695b793-1b02-4f02-8d24-0a0cf3da3b43
Inspection Facts
Voluntary Action Indicated (VAI)
Objectionable conditions were found, but FDA is not prepared to take or recommend regulatory action.
- Inspection number
- 1130944
- FDA center
- Human Drugs
- Project area
- Bioresearch Monitoring
FDA Citations
5- 21 CFR 314.80(b)Failure to review ADE information
- 21 CFR 314.80(c)(2)Late submission of annual safety reports
- 21 CFR 314.80(c)(2)Late submission of quarterly safety reports
- 21 CFR 314.80(b)Failure to develop written procedures
- 21 CFR 314.80(c)(2)(ii)(B)Late submission of an ICSR
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Other FDA inspections of Larken Laboratories, Inc.
3| Date | Classification | Office | Project area |
|---|---|---|---|
| October 24, 2024 | NAI | Center for Drug Evaluation and Research | Bioresearch Monitoring |
| April 13, 2012 | VAI | Center for Drug Evaluation and Research | Unapproved and Misbranded Drugs |
| March 3, 2011 | NAI | Center for Drug Evaluation and Research | Drug Quality Assurance |
Other documents for Larken Laboratories, Inc.
- FDA Inspection 1252804 - 2024-10-24
- FDA Inspection 777598 - 2012-04-13
- FDA Inspection 715719 - 2011-03-03
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