FDA Inspection

Chara Biologics, Inc.August 16, 2024

Chara Biologics, Inc. – FDA Inspection, Aug 16, 2024

Record Details

This FDA Inspection record concerns Chara Biologics, Inc., with an inspection on August 16, 2024, issued by the Center for Biologics Evaluation and Research, covering biologics.

Company: Chara Biologics, Inc.
Inspection Date: August 16, 2024
Product Type: Biologics
Office: Center for Biologics Evaluation and Research
People: Emily B. Camire (Issuing Officer)
Laurissa S. Flowers (Issuing Officer)

View Company Profile

ID · 17bfe476-af75-4c2a-af5d-98a745f9a575

Inspection Facts

Official Action Indicated (OAI)

Significant objectionable conditions were found and regulatory or administrative action is recommended.

Inspection number: 1246548
FDA center: Biologics
Project area: Human Cellular, Tissue, and Gene Therapies
Enforcement: Warning Letter

FDA Citations

21 CFR 211.180(b)Record maintenance 1 year (except exempt OTC)
21 CFR 211.196Distribution Record Requirements
21 CFR 211.137(a)Expiration date lacking
21 CFR 211.25(a)Training--operations, GMPs, written procedures
21 CFR 1271.50(a)Determination based on screening and testing
21 CFR 211.134(a)Correct labels during finishing operations
21 CFR 211.198(a)Procedures to be written and followed
21 CFR 211.125(a)Strict control not exercised over labeling issued
21 CFR 211.130(c)Lot or control number assigned
Name, address on label or documentation

Showing 10 of 13 citations.

Full citation text and observation details available on the Dashboard.

Discuss this record with AI

KeyPedia

ChatGPT

Claude

Perplexity

Grok

Copilot

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.

Explore Chara Biologics, Inc.