FDA Inspection
Hiers Enterprises, LLC dba Northwest Compounding PharmacyHiers Enterprises, LLC dba Northwest Compounding Pharmacy – FDA Inspection, Nov 14, 2018
Record Details
This FDA Inspection record concerns Hiers Enterprises, LLC dba Northwest Compounding Pharmacy, with an inspection on November 14, 2018, issued by the Seattle District Office, covering human drugs.
- Inspection Date
- November 14, 2018
- Product Type
- Human Drugs
- Office
- Seattle District Office
- Person
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ID · b2cf72b1-a56c-4f81-b614-c43325cf1c41
Inspection Facts
- Inspection number
- 1071602
- FDA center
- Human Drugs
- Project area
- Drug Quality Assurance
- Outcome
- Form 483 issued
FDA Citations
10- 21 CFR 211.113(b)Procedures for sterile drug products
- 21 CFR 211.165(a)Testing and release for distribution
- 21 CFR 211.165(b)Microbiological testing
- 21 CFR 211.166(a)Lack of written stability program
- 21 CFR 211.167(a)Sterility/pyrogen-free testing
- 21 CFR 211.28(a)Clothing appropriate for duties performed
- 21 CFR 211.42(c)(10)(iii)Air Supply
- 21 CFR 211.42(c)(10)(iv)Environmental Monitoring System
- 21 CFR 211.42(c)(10)(v)Cleaning System
- 21 CFR 211.84(d)(6)Microbiological Contamination Exam
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Other FDA inspections of Hiers Enterprises, LLC dba Northwest Compounding Pharmacy
2| Date | Classification | Office | Project area |
|---|---|---|---|
| June 16, 2022 | NAI | Center for Drug Evaluation and Research | Drug Quality Assurance |
| November 10, 2021 | VAI | Center for Drug Evaluation and Research | Drug Quality Assurance |
Other documents for Hiers Enterprises, LLC dba Northwest Compounding Pharmacy
- FDA Inspection 1173041 - 2022-06-16
- FDA Inspection 1157204 - 2021-11-10
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