FDA Inspection
ASP CaresASP Cares – FDA Inspection, Aug 23, 2018
Record Details
This FDA Inspection record concerns ASP Cares, with an inspection on August 23, 2018, issued by the Center for Drug Evaluation and Research, covering drugs.
View Company Profile
ID · c4921dc5-e9b3-4081-8b14-ae56b99194b4
Inspection Facts
Official Action Indicated (OAI)
Significant objectionable conditions were found and regulatory or administrative action is recommended.
- Inspection number
- 1062902
- FDA center
- Human Drugs
- Project area
- Drug Quality Assurance
- Outcome
- Form 483 issued
FDA Citations
6- 21 CFR 211.42(c)(10)(iii)Air Supply
- 21 CFR 211.42(c)(10)(iv)Environmental Monitoring System
- 21 CFR 211.67(a)Cleaning / Sanitizing / Maintenance
- 21 CFR 211.194(a)(2)Statement of methods and data
- 21 CFR 211.113(b)Validation lacking for sterile drug products
- 21 CFR 211.186(b)(9)Manufacturing Instructions and Specifications
Full citation text and observation details available on the Dashboard.
Other FDA inspections of ASP Cares
1| Date | Classification | Office | Project area |
|---|---|---|---|
| March 2, 2017 | VAI | Center for Drug Evaluation and Research | Drug Quality Assurance |
Other documents for ASP Cares
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.