FDA Inspection
Grandpa's Compounding Pharmacy, Inc.Grandpa's Compounding Pharmacy, Inc. – FDA Inspection, Sep 10, 2013
Record Details
This FDA Inspection record concerns Grandpa's Compounding Pharmacy, Inc., with an inspection on September 10, 2013, issued by the Center for Drug Evaluation and Research, covering drugs.
- Inspection Date
- September 10, 2013
- Product Type
- Drugs
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ID · bed952ea-c92c-46c7-8190-b35c3f52e8bf
Inspection Facts
Official Action Indicated (OAI)
Significant objectionable conditions were found and regulatory or administrative action is recommended.
- Inspection number
- 847488
- FDA center
- Human Drugs
- Project area
- Drug Quality Assurance
FDA Citations
10- 21 CFR 211.42(c)(10)(iii)Air Supply
- 21 CFR 211.58Buildings not maintained in good state of repair
- 21 CFR 211.28(a)Clothing appropriate for duties performed
- 21 CFR 211.67(a)Cleaning / Sanitizing / Maintenance
- 21 CFR 211.65(a)Equipment construction - reactive surfaces
- 21 CFR 211.63Equipment Design, Size and Location
- 21 CFR 211.25(b)Supervisor Training/Education/Experience
- 21 CFR 211.194(a)(2)Statement of methods and data
- 21 CFR 211.113(b)Procedures for sterile drug products
- 21 CFR 211.68(a)Written calibration / inspection records not kept
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Other FDA inspections of Grandpa's Compounding Pharmacy, Inc.
1| Date | Classification | Office | Project area |
|---|---|---|---|
| September 18, 2015 | VAI | Center for Drug Evaluation and Research | Drug Quality Assurance |
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