FDA Inspection
BSO, LLCBSO, LLC – FDA Inspection, Jun 27, 2025
Record Details
This FDA Inspection record concerns BSO, LLC, with an inspection on June 27, 2025, issued by the Denver District Office, covering human drugs.
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ID · b8e16a8a-24fd-464d-8dae-0838b0564446
Inspection Facts
Official Action Indicated (OAI)
Significant objectionable conditions were found and regulatory or administrative action is recommended.
- Inspection number
- 1274469
- FDA center
- Human Drugs
- Project area
- Drug Quality Assurance
- Outcome
- Form 483 issued
FDA Citations
8- 21 CFR 211.100(a)Absence of Written Procedures
- 21 CFR 211.100(b)SOPs not followed / documented
- 21 CFR 211.113(b)Validation lacking for sterile drug products
- 21 CFR 211.165(a)Testing and release for distribution
- 21 CFR 211.166(a)(3)Valid stability test methods
- 21 CFR 211.186(b)(9)Manufacturing Instructions and Specifications
- 21 CFR 211.63Equipment Design, Size and Location
- 21 CFR 211.67(b)Written procedures not established/followed
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