FDA Inspection
Beyond Technology Corporation NanchangBeyond Technology Corporation Nanchang – FDA Inspection, Nov 11, 2015
Record Details
This FDA Inspection record concerns Beyond Technology Corporation Nanchang, with an inspection on November 11, 2015, issued by the Center for Drug Evaluation and Research, covering drugs.
- Inspection Date
- November 11, 2015
- Product Type
- Drugs
View Company Profile
ID · 89087692-b337-40e6-960f-8c2aff1b7859
Inspection Facts
Official Action Indicated (OAI)
Significant objectionable conditions were found and regulatory or administrative action is recommended.
- Inspection number
- 949776
- FDA center
- Human Drugs
- Project area
- Drug Quality Assurance
FDA Citations
13- 21 CFR 211.44Adequate lighting not provided
- 21 CFR 211.56(a)Sanitation--buildings not clean, free of infestation
- 21 CFR 211.101(b)Measured components for manufacturing
- 21 CFR 211.25(a)Training--operations, GMPs, written procedures
- 21 CFR 211.186(a)Written procedures followed
- 21 CFR 211.28(a)Protective Apparel Not Worn
- 21 CFR 211.180(c)Records not made readily available to FDA
- 21 CFR 211.22(c)Approve or reject procedures or specs
- 21 CFR 211.100(a)Absence of Written Procedures
- 21 CFR 211.166(a)Lack of written stability program
Showing 10 of 13 citations.
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.