FDA Inspection
Premier Trends LLCPremier Trends LLC – FDA Inspection, Sep 29, 2021
Record Details
This FDA Inspection record concerns Premier Trends LLC, with an inspection on September 29, 2021, issued by the Center for Drug Evaluation and Research, covering drugs.
- Company
- Premier Trends LLC
- Inspection Date
- September 29, 2021
- Product Type
- Drugs
View Company Profile
ID · 015e9e8b-37d9-472a-94d4-4a628d75b2f9
Inspection Facts
Official Action Indicated (OAI)
Significant objectionable conditions were found and regulatory or administrative action is recommended.
- Inspection number
- 1153243
- FDA center
- Human Drugs
- Project area
- Drug Quality Assurance
- Enforcement
- Warning Letter
FDA Citations
5- 21 CFR 211.25(a)Training--operations, GMPs, written procedures
- 21 CFR 211.68(a)Calibration/Inspection/Checking not done
- 21 CFR 211.165(a)Testing and release for distribution
- 21 CFR 211.188(b)Batch production and Batch Control Record Requirements
- 21 CFR 211.22(d)Procedures not in writing, fully followed
Full citation text and observation details available on the Dashboard.
Other FDA inspections of Premier Trends LLC
1| Date | Classification | Office | Project area |
|---|---|---|---|
| June 28, 2019 | OAI | Center for Drug Evaluation and Research | Drug Quality Assurance |
Other documents for Premier Trends LLC
Document or profile
One record shows the event. A profile shows the pattern.
Buy this document for the source file and details behind this single event.
Choose full profile access to connect related records, sites, people, citations, and enforcement history in one view.