FDA Inspection
American Cell Technology, LLC.American Cell Technology, LLC. – FDA Inspection, Oct 29, 2021
Record Details
This FDA Inspection record concerns American Cell Technology, LLC., with an inspection on October 29, 2021, issued by the Center for Biologics Evaluation and Research, covering biologics.
- Inspection Date
- October 29, 2021
- Product Type
- Biologics
View Company Profile
ID · 5d0661a1-f115-4650-a8b1-c7986722d6e3
Inspection Facts
Voluntary Action Indicated (VAI)
Objectionable conditions were found, but FDA is not prepared to take or recommend regulatory action.
- Inspection number
- 1155652
- FDA center
- Biologics
- Project area
- Human Cellular, Tissue, and Gene Therapies
FDA Citations
9- 21 CFR 211.42(c)(10)(v)Cleaning System
- 21 CFR 211.42(c)(10)(iv)Environmental Monitoring System
- 21 CFR 211.130Procedures are written, and followed
- 21 CFR 211.113(b)Validation lacking for sterile drug products
- 21 CFR 211.67(c)Cleaning/maintenance records not kept
- 21 CFR 211.165(e)Test methods
- 21 CFR 211.100(a)Absence of Written Procedures
- 21 CFR 211.22(d)Procedures not in writing, fully followed
- 21 CFR 211.80(a)Procedures To Be in Writing
Full citation text and observation details available on the Dashboard.
Document or profile
One record shows the event. A profile shows the pattern.
Buy this document for the source file and details behind this single event.
Choose full profile access to connect related records, sites, people, citations, and enforcement history in one view.