FDA Inspection
Delta Pharma, Inc.FDA Inspection 851435 - Delta Pharma, Inc. - October 02, 2013
Record Details
This FDA Inspection record concerns Delta Pharma, Inc., with an inspection on October 2, 2013, issued by the Center for Drug Evaluation and Research, covering drugs.
- Company
- Delta Pharma, Inc.
- Inspection Date
- October 2, 2013
- Product Type
- Drugs
View Company Profile
ID · 0f077772-371c-416c-a32a-1c0745b971dc
Inspection Facts
Official Action Indicated (OAI)
Significant objectionable conditions were found and regulatory or administrative action is recommended.
- Inspection number
- 851435
- FDA center
- Human Drugs
- Project area
- Drug Quality Assurance
FDA Citations
9- 21 CFR 211.42(c)(10)(iii)Air Supply
- 21 CFR 211.42(c)(10)(v)Cleaning System
- 21 CFR 211.42(c)(10)(iv)Environmental Monitoring System
- 21 CFR 211.28(a)Clothing appropriate for duties performed
- 21 CFR 211.84(d)(6)Microbiological Contamination Exam
- 21 CFR 211.63Equipment Design, Size and Location
- 21 CFR 211.113(b)Validation lacking for sterile drug products
- 21 CFR 211.84(d)(2)Reports of Analysis (Components)
- 21 CFR 211.68(a)Calibration/Inspection/Checking not done
Full citation text and observation details available on the Dashboard.
Other FDA inspections of Delta Pharma, Inc.
7| Date | Classification | Office | Project area |
|---|---|---|---|
| November 21, 2025 | Not classified | New Orleans District Office | Drug Quality Assurance |
| April 12, 2024 | Not classified | New Orleans District Office | Drug Quality Assurance |
| June 2, 2023 | VAI | New Orleans District Office | |
| May 20, 2022 | VAI | Center for Drug Evaluation and Research | Drug Quality Assurance |
| February 23, 2017 | OAI | Center for Drug Evaluation and Research | Drug Quality Assurance |
Other documents for Delta Pharma, Inc.
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.