FDA Inspection
Coast Quality Pharmacy, LLCCoast Quality Pharmacy, LLC – FDA Inspection, May 9, 2019
Record Details
This FDA Inspection record concerns Coast Quality Pharmacy, LLC, with an inspection on May 9, 2019, issued by the Center for Drug Evaluation and Research, covering drugs.
View Company Profile
ID · 482e5f3b-057f-408d-8c67-7976e9ecd004
Inspection Facts
Voluntary Action Indicated (VAI)
Objectionable conditions were found, but FDA is not prepared to take or recommend regulatory action.
- Inspection number
- 1089129
- FDA center
- Human Drugs
- Project area
- Drug Quality Assurance
- Outcome
- Form 483 issued
FDA Citations
5- FDCA 501(a)(2)(A)Disinfecting and cleaning agents, ISO 5 area
- 21 CFR 211.113(b)Validation lacking for sterile drug products
- 21 CFR 211.166(a)(3)Valid stability test methods
- FDCA 501(a)(2)(A)Actionable microbial contamination, adjacent area
- FDCA 501(a)(2)(A)Use of non-pharmaceutical grade components
Full citation text and observation details available on the Dashboard.
Other FDA inspections of Coast Quality Pharmacy, LLC
1| Date | Classification | Office | Project area |
|---|---|---|---|
| May 7, 2018 | OAI | Center for Drug Evaluation and Research | Drug Quality Assurance |
Other documents for Coast Quality Pharmacy, LLC
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.