FDA Inspection
Promise Pharmacy, LLCPromise Pharmacy, LLC – FDA Inspection, Oct 25, 2018
Record Details
This FDA Inspection record concerns Promise Pharmacy, LLC, with an inspection on October 25, 2018, issued by the Center for Drug Evaluation and Research, covering drugs.
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ID · 18f47f4b-47df-4af7-8b0b-329132bffc32
Inspection Facts
Official Action Indicated (OAI)
Significant objectionable conditions were found and regulatory or administrative action is recommended.
- Inspection number
- 1069714
- FDA center
- Human Drugs
- Project area
- Drug Quality Assurance
- Outcome
- Form 483 issued
- Enforcement
- Warning Letter
FDA Citations
7- 21 CFR 211.165(b)Microbiological testing
- 21 CFR 211.67(a)Cleaning / Sanitizing / Maintenance
- 21 CFR 211.113(b)Procedures for sterile drug products
- 21 CFR 211.165(a)Testing and release for distribution
- 21 CFR 211.42(b)Product flow through building is inadequate
- 21 CFR 211.22(c)Approve or reject procedures or specs
- 21 CFR 211.166(a)Lack of written stability program
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Other FDA inspections of Promise Pharmacy, LLC
1| Date | Classification | Office | Project area |
|---|---|---|---|
| September 23, 2021 | VAI | Center for Drug Evaluation and Research | Drug Quality Assurance |
Other documents for Promise Pharmacy, LLC
- FDA Inspection 1153148 - 2021-09-23
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