FDA Inspection
Strive Pharmacy LLCStrive Pharmacy LLC – FDA Inspection, Sep 28, 2026
Record Details
This FDA Inspection record concerns Strive Pharmacy LLC, with an inspection on September 28, 2026, issued by the Denver District Office, covering human drugs.
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ID · 2c7fef5d-dd6d-4b12-a4df-77b3bcf1783a
Inspection Facts
- Inspection number
- 1328698
- FDA center
- Human Drugs
- Project area
- Drug Quality Assurance
- Outcome
- Form 483 issued
FDA Citations
10- FDCA 501(a)(2)(A)Beta-lactam, hazardous, highly potent drugs, prevention of cross-contamination
- FDCA 501(a)(2)(A)Improper gowning, contamination
- FDCA 501(a)(2)(A)Inadequate smoke studies
- FDCA 501(a)(2)(A)Lack of/inadequate, environmental monitoring
- FDCA 501(a)(2)(A)Lack of, personnel sampling
- FDCA 501(a)(2)(A)Media fills, failure
- FDCA 501(a)(2)(A)Microbial contamination was present, ISO 5/areas adjacent
- FDCA 501(a)(2)(A)Non-sterile disinfecting agents, ISO 5 area/classified areas
- FDCA 501(a)(2)(A)Personnel moving quickly, disrupting unidirectional airflow
- FDCA 501(a)(2)(A)Production areas, difficult to clean/particle generating
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