FDA Inspection
Elkhart PharmacyElkhart Pharmacy – FDA Inspection, Dec 21, 2015
Record Details
This FDA Inspection record concerns Elkhart Pharmacy, with an inspection on December 21, 2015, issued by the Center for Drug Evaluation and Research, covering drugs.
- Company
- Elkhart Pharmacy
- Inspection Date
- December 21, 2015
- Product Type
- Drugs
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ID · 1141f3bf-22b0-4eeb-96c2-4af17fc1bb97
Inspection Facts
Official Action Indicated (OAI)
Significant objectionable conditions were found and regulatory or administrative action is recommended.
- Inspection number
- 954115
- FDA center
- Human Drugs
- Project area
- Drug Quality Assurance
FDA Citations
4- 21 CFR 211.42(c)(10)(vi)Equipment to control conditions
- 21 CFR 211.42(c)(10)(v)Cleaning System
- 21 CFR 211.28(a)Protective Apparel Not Worn
- 21 CFR 211.166(a)Results not used for expiration dates, storage cond.
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