FDA Inspection
Ascend Laboratories, LLCAscend Laboratories, LLC – FDA Inspection, Nov 10, 2021
Record Details
This FDA Inspection record concerns Ascend Laboratories, LLC, with an inspection on November 10, 2021, issued by the Center for Drug Evaluation and Research, covering drugs.
- Company
- Ascend Laboratories, LLC
- Inspection Date
- November 10, 2021
- Product Type
- Drugs
View Company Profile
ID · fd0bba8a-4dbd-4058-b1ef-0ba0f4ad2aa3
Inspection Facts
Voluntary Action Indicated (VAI)
Objectionable conditions were found, but FDA is not prepared to take or recommend regulatory action.
- Inspection number
- 1156395
- FDA center
- Human Drugs
- Project area
- Bioresearch Monitoring
FDA Citations
3- 21 CFR 314.81(b)(2)Timely submission
- 21 CFR 314.80(c)(2)Late submission of annual safety reports
- 21 CFR 314.80(b)Failure to develop written procedures
Full citation text and observation details available on the Dashboard.
Other FDA inspections of Ascend Laboratories, LLC
4| Date | Classification | Office | Project area |
|---|---|---|---|
| June 24, 2021 | VAI | Center for Drug Evaluation and Research | Drug Quality Assurance |
| July 6, 2017 | NAI | Center for Drug Evaluation and Research | Unapproved and Misbranded Drugs |
| December 11, 2013 | OAI | Center for Drug Evaluation and Research | Unapproved and Misbranded Drugs |
| February 10, 2011 | NAI | Center for Drug Evaluation and Research | Bioresearch Monitoring |
Other documents for Ascend Laboratories, LLC
- FDA Inspection 1144680 - 2021-06-24
- FDA Inspection 1023638 - 2017-07-06
- FDA Inspection 856772 - 2013-12-11
- FDA Inspection 709952 - 2011-02-10
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