FDA Inspection
Deltex Pharmaceuticals, IncDeltex Pharmaceuticals, Inc – FDA Inspection, Apr 16, 2010
Record Details
This FDA Inspection record concerns Deltex Pharmaceuticals, Inc, with an inspection on April 16, 2010, issued by the Center for Drug Evaluation and Research, covering drugs.
- Company
- Deltex Pharmaceuticals, Inc
- Inspection Date
- April 16, 2010
- Product Type
- Drugs
View Company Profile
ID · bee22412-51c9-4a2f-b117-82502db98ce2
Inspection Facts
Official Action Indicated (OAI)
Significant objectionable conditions were found and regulatory or administrative action is recommended.
- Inspection number
- 653865
- FDA center
- Human Drugs
- Project area
- Drug Quality Assurance
FDA Citations
8- 21 CFR 211.110(a)Control procedures fail to include the following
- 21 CFR 211.160(b)Scientifically sound laboratory controls
- 21 CFR 211.34Consultant Records
- 21 CFR 211.167(c)Controlled release test methods written, followed
- 21 CFR 211.165(e)Test methods
- 21 CFR 211.160(a)Lab controls established, including changes
- 21 CFR 211.166(a)(3)Valid stability test methods
- 21 CFR 211.180(e)(2)Items to cover on annual reviews
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.