FDA Inspection
NeoBiotech Global CorporationNeoBiotech Global Corporation – FDA Inspection, May 13, 2019
Record Details
This FDA Inspection record concerns NeoBiotech Global Corporation, with an inspection on May 13, 2019, issued by the Center for Drug Evaluation and Research, covering drugs.
View Company Profile
ID · a687a9ae-dfdc-41bb-aa8f-a48b807c633c
Inspection Facts
Voluntary Action Indicated (VAI)
Objectionable conditions were found, but FDA is not prepared to take or recommend regulatory action.
- Inspection number
- 1090023
- FDA center
- Human Drugs
- Project area
- Drug Quality Assurance
- Outcome
- Form 483 issued
FDA Citations
8- 21 CFR 211.188Prepared for each batch, include complete information
- 21 CFR 211.63Equipment Design, Size and Location
- 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 211.165(a)Testing and release for distribution
- 21 CFR 211.100(a)Absence of Written Procedures
- 21 CFR 211.22(a)Lack of quality control unit
- 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.