FDA Inspection
Amniotic Therapies LLCFDA Inspection 975148 - Amniotic Therapies LLC - May 04, 2016
Record Details
This FDA Inspection record concerns Amniotic Therapies LLC, with an inspection on May 4, 2016, issued by the Center for Biologics Evaluation and Research, covering biologics.
- Company
- Amniotic Therapies LLC
- Inspection Date
- May 4, 2016
- Product Type
- Biologics
View Company Profile
ID · 6240016e-1e76-4324-bbfe-268613e6048e
Inspection Facts
Official Action Indicated (OAI)
Significant objectionable conditions were found and regulatory or administrative action is recommended.
- Inspection number
- 975148
- FDA center
- Biologics
- Project area
- Human Cellular, Tissue, and Gene Therapies
FDA Citations
9- 21 CFR 1271.350(a)(1)Adverse reaction reporting to FDA
- 21 CFR 1271.195(c)Monitoring-microorganisms where appropriate
- 21 CFR 1271.220(a)Causing contamination, increasing risks
- 21 CFR 1271.265(a)Evaluation--microorganisms, damage
- 21 CFR 1271.180(a)Design adequate to bar spread of CD"s
- 21 CFR 1271.225Verification/validation
- 21 CFR 1271.230(a)Validation & approval--established procedures
- 21 CFR 1271.55(b)(1)Statement re: certified testing lab
- 21 CFR 1271.55(b)(3)Name and address on summary
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