FDA Inspection
Compound Preferred LLCCompound Preferred LLC – FDA Inspection, Aug 1, 2019
Record Details
This FDA Inspection record concerns Compound Preferred LLC, with an inspection on August 1, 2019, issued by the Seattle District Office, covering human drugs.
- Office
- Seattle District Office
- Person
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ID · 9bc0090c-07a8-4563-8445-3b9bdcf35d19
Inspection Facts
- Inspection number
- 1098749
- FDA center
- Human Drugs
- Project area
- Drug Quality Assurance
- Outcome
- Form 483 issued
FDA Citations
7- 21 CFR 211.113(b)Validation lacking for sterile drug products
- 21 CFR 211.165(a)Testing and release for distribution
- 21 CFR 211.166(a)Lack of written stability program
- 21 CFR 211.167(a)Sterility/pyrogen-free testing
- 21 CFR 211.192No written record of investigation
- 21 CFR 211.42(c)(10)(iv)Environmental Monitoring System
- 21 CFR 211.42(c)(10)(v)Cleaning System
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Other FDA inspections of Compound Preferred LLC
2| Date | Classification | Office | Project area |
|---|---|---|---|
| December 17, 2021 | OAI | Center for Drug Evaluation and Research | Drug Quality Assurance |
| March 1, 2017 | OAI | Center for Drug Evaluation and Research | Drug Quality Assurance |
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