FDA Inspection
Canyon Rush, LLCCanyon Rush, LLC – FDA Inspection, Apr 15, 2022
Record Details
This FDA Inspection record concerns Canyon Rush, LLC, with an inspection on April 15, 2022, issued by the Center for Drug Evaluation and Research, covering drugs.
- Company
- Canyon Rush, LLC
- Inspection Date
- April 15, 2022
- Product Type
- Drugs
View Company Profile
ID · 56b6f273-fec0-467e-b60a-32cf4e4a2770
Inspection Facts
Voluntary Action Indicated (VAI)
Objectionable conditions were found, but FDA is not prepared to take or recommend regulatory action.
- Inspection number
- 1167126
- FDA center
- Human Drugs
- Project area
- Drug Quality Assurance
FDA Citations
7- 21 CFR 211.68(b)Computer control of master formula records
- 21 CFR 211.42(c)(10)(iv)Environmental Monitoring System
- 21 CFR 211.46(b)Equipment for Environmental Control
- 21 CFR 211.113(b)Procedures for sterile drug products
- 21 CFR 211.113(b)Validation lacking for sterile drug products
- 21 CFR 211.22(d)Procedures not in writing, fully followed
- 21 CFR 211.192Written record of investigation incomplete
Full citation text and observation details available on the Dashboard.
Other FDA inspections of Canyon Rush, LLC
7| Date | Classification | Office | Project area |
|---|---|---|---|
| May 15, 2026 | Not classified | New York District Office | Drug Quality Assurance |
| August 23, 2024 | Not classified | New York District Office | |
| May 27, 2021 | NAI | Center for Biologics Evaluation and Research | Vaccines and Allergenic Products |
| May 4, 2016 | NAI | Center for Devices and Radiological Health | Compliance: Devices |
| October 9, 2014 | NAI | Center for Drug Evaluation and Research | Drug Quality Assurance |
Other documents for Canyon Rush, LLC
- FDA Inspection 1317524 - 2026-05-15
- FDA Inspection 1247920 - 2024-08-23
- FDA Inspection 1142658 - 2021-05-27
- FDA Inspection 969391 - 2016-05-04
- FDA Inspection 900822 - 2014-10-09
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