FDA Inspection
Americare Compounding, LLC.Americare Compounding, LLC. – FDA Inspection, Jun 19, 2013
Record Details
This FDA Inspection record concerns Americare Compounding, LLC., with an inspection on June 19, 2013, issued by the Center for Veterinary Medicine, covering veterinary.
- Company
- Americare Compounding, LLC.
- Inspection Date
- June 19, 2013
- Product Type
- Veterinary
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ID · 70ff37c4-0bb9-41c0-995b-b44f31d146c7
Inspection Facts
Official Action Indicated (OAI)
Significant objectionable conditions were found and regulatory or administrative action is recommended.
- Inspection number
- 835774
- FDA center
- Animal Drugs & Feeds
- Project area
- Monitoring of Marketed Animal Drugs, Feed, and Devices
FDA Citations
12- 21 CFR 211.46(d)Penicillin air handling systems not kept separate
- 21 CFR 211.166(b)Adequate number of batches on stability
- 21 CFR 211.28(a)Clothing appropriate for duties performed
- 21 CFR 211.67(a)Cleaning / Sanitizing / Maintenance
- 21 CFR 211.63Equipment Design, Size and Location
- 21 CFR 211.160(b)Scientifically sound laboratory controls
- 21 CFR 211.113(b)Procedures for sterile drug products
- 21 CFR 211.113(b)Validation lacking for sterile drug products
- 21 CFR 211.170(b)Reserve samples identified, representative, stored
- 21 CFR 211.42(d)Penicillin processing area not kept separate
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