FDA Inspection
EUCYT Laboratories LLCEUCYT Laboratories LLC – FDA Inspection, Nov 21, 2019
Record Details
This FDA Inspection record concerns EUCYT Laboratories LLC, with an inspection on November 21, 2019, issued by the Center for Biologics Evaluation and Research, covering biologics.
- Company
- EUCYT Laboratories LLC
- Inspection Date
- November 21, 2019
- Product Type
- Biologics
View Company Profile
ID · a8542afc-83c0-45a5-8e7e-f689c98b643e
Inspection Facts
Official Action Indicated (OAI)
Significant objectionable conditions were found and regulatory or administrative action is recommended.
- Inspection number
- 1112106
- FDA center
- Biologics
- Project area
- Blood and Blood Products
- Enforcement
- Warning Letter
FDA Citations
15- 21 CFR 211.42(c)(10)(v)Cleaning System
- 21 CFR 211.42(c)(10)(iv)Environmental Monitoring System
- 21 CFR 1271.75(d)Donors with risks not determined ineligible
- 21 CFR 211.160(b)(3)Drug product sample
- 21 CFR 211.137(a)Expiration date lacking
- 21 CFR 1271.50(a)Determination based on screening and testing
- 21 CFR 211.176Failing to test for penicillin cross-contamination
- 21 CFR 211.198(a)Procedures to be written and followed
- 21 CFR 211.113(b)Validation lacking for sterile drug products
- 21 CFR 1271.47(a)Design of procedures to ensure compliance
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