FDA Inspection
Sports Tek Medical, Inc.Sports Tek Medical, Inc. – FDA Inspection, Jan 23, 2025
Record Details
This FDA Inspection record concerns Sports Tek Medical, Inc., with an inspection on January 23, 2025, issued by the Los Angeles District Office, covering biologics.
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ID · de75eb10-b7c4-474d-9aaf-6ba62403534c
Inspection Facts
Voluntary Action Indicated (VAI)
Objectionable conditions were found, but FDA is not prepared to take or recommend regulatory action.
- Inspection number
- 1258967
- FDA center
- Biologics
- Project area
- Human Cellular, Tissue, and Gene Therapies
- Outcome
- Form 483 issued
FDA Citations
3- 21 CFR 1271.265(a)Evaluation--microorganisms, damage
- 21 CFR 1271.270(d)Retention time (10 year rules)
- 21 CFR 1271.260(e)Storage temperatures recorded, maintained
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Other FDA inspections of Sports Tek Medical, Inc.
1| Date | Classification | Office | Project area |
|---|---|---|---|
| May 25, 2017 | NAI | Center for Biologics Evaluation and Research | Human Cellular, Tissue, and Gene Therapies |
Other documents for Sports Tek Medical, Inc.
- FDA Inspection 1015594 - 2017-05-25
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