FDA Inspection
Norwood Packaging Ltd.Norwood Packaging Ltd. – FDA Inspection, Sep 19, 2014
Record Details
This FDA Inspection record concerns Norwood Packaging Ltd., with an inspection on September 19, 2014, issued by the Center for Drug Evaluation and Research, covering drugs.
- Company
- Norwood Packaging Ltd.
- Inspection Date
- September 19, 2014
- Product Type
- Drugs
View Company Profile
ID · e508ca53-06c8-4e8e-86c6-380dc7a78aa7
Inspection Facts
Voluntary Action Indicated (VAI)
Objectionable conditions were found, but FDA is not prepared to take or recommend regulatory action.
- Inspection number
- 899835
- FDA center
- Human Drugs
- Project area
- Drug Quality Assurance
FDA Citations
14- 21 CFR 211.68(b)Computer control of master formula records
- 21 CFR 211.125(c)Label reconciliation discrepancies evaluation/investigation
- 21 CFR 211.67(a)Cleaning / Sanitizing / Maintenance
- 21 CFR 211.160(b)Scientifically sound laboratory controls
- 21 CFR 211.113(a)Procedures for non-sterile drug products
- 21 CFR 211.165(a)Testing and release for distribution
- 21 CFR 211.25(c)Inadequate number of personnel
- 21 CFR 211.22(a)Contract drug products--lack of responsibility
- 21 CFR 211.100(a)Absence of Written Procedures
- 21 CFR 211.22(d)Procedures not in writing, fully followed
Showing 10 of 14 citations.
Full citation text and observation details available on the Dashboard.
Other FDA inspections of Norwood Packaging Ltd.
1| Date | Classification | Office | Project area |
|---|---|---|---|
| January 25, 2012 | VAI | Center for Drug Evaluation and Research | Drug Quality Assurance |
Other documents for Norwood Packaging Ltd.
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.