FDA Inspection
Skyless LLCSkyless LLC – FDA Inspection, May 16, 2022
Record Details
This FDA Inspection record concerns Skyless LLC, with an inspection on May 16, 2022, issued by the Center for Drug Evaluation and Research, covering drugs.
- Company
- Skyless LLC
- Inspection Date
- May 16, 2022
- Product Type
- Drugs
View Company Profile
ID · 65efa5e7-c2e5-44cc-8c75-593f14194577
Inspection Facts
Official Action Indicated (OAI)
Significant objectionable conditions were found and regulatory or administrative action is recommended.
- Inspection number
- 1168548
- 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 211.84(d)(2)Component identification test
- 21 CFR 211.100(a)Absence of Written Procedures
- 21 CFR 211.22(d)Procedures not in writing, fully followed
- 21 CFR 211.67(b)Written procedures not established/followed
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