FDA Inspection
HHCS Pharmacy Inc.HHCS Pharmacy Inc. – FDA Inspection, Jul 28, 2014
Record Details
This FDA Inspection record concerns HHCS Pharmacy Inc., with an inspection on July 28, 2014, issued by the Center for Drug Evaluation and Research, covering drugs.
- Company
- HHCS Pharmacy Inc.
- Inspection Date
- July 28, 2014
- Product Type
- Drugs
View Company Profile
ID · 01ebc925-0ac3-4582-a45d-797d6c7ca661
Inspection Facts
Official Action Indicated (OAI)
Significant objectionable conditions were found and regulatory or administrative action is recommended.
- Inspection number
- 889307
- FDA center
- Human Drugs
- Project area
- Drug Quality Assurance
FDA Citations
8- 21 CFR 211.42(c)(10)(iii)Air Supply
- 21 CFR 211.42(c)(10)(v)Cleaning System
- 21 CFR 211.42(c)(10)(iv)Environmental Monitoring System
- 21 CFR 211.28(a)Clothing appropriate for duties performed
- 21 CFR 211.167(a)Sterility/pyrogen-free testing
- 21 CFR 211.113(b)Validation lacking for sterile drug products
- 21 CFR 211.42(c)(10)Aseptic Processing Area
- 21 CFR 211.165(a)Testing and release for distribution
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Other FDA inspections of HHCS Pharmacy Inc.
1| Date | Classification | Office | Project area |
|---|---|---|---|
| October 14, 2016 | NAI | Center for Drug Evaluation and Research | Drug Quality Assurance |
Other documents for HHCS Pharmacy Inc.
- FDA Inspection 989435 - 2016-10-14
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