FDA Inspection
Bio-Derm Laboratories, IncBio-Derm Laboratories, Inc – FDA Inspection, Mar 30, 2012
Record Details
This FDA Inspection record concerns Bio-Derm Laboratories, Inc, with an inspection on March 30, 2012, issued by the Center for Veterinary Medicine, covering veterinary.
- Company
- Bio-Derm Laboratories, Inc
- Inspection Date
- March 30, 2012
- Product Type
- Veterinary
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ID · 5f9e1c3e-93f4-4e2f-a501-9790cacfc5d1
Inspection Facts
Voluntary Action Indicated (VAI)
Objectionable conditions were found, but FDA is not prepared to take or recommend regulatory action.
- Inspection number
- 774152
- FDA center
- Animal Drugs & Feeds
- Project area
- Monitoring of Marketed Animal Drugs, Feed, and Devices
FDA Citations
8- 21 CFR 211.188(b)(3)Identification of each component or in-process material
- 21 CFR 211.80(d)Status of Each Lot Identified
- 21 CFR 211.67(a)Cleaning / Sanitizing / Maintenance
- 21 CFR 211.63Equipment Design, Size and Location
- 21 CFR 211.84(d)(2)Establish reliability of supplier"s C of A
- 21 CFR 211.160(a)Lab controls established, including changes
- 21 CFR 211.166(a)Written program not followed
- 21 CFR 211.180(e)(1)Review of representative number of batches
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Other FDA inspections of Bio-Derm Laboratories, Inc
6| Date | Classification | Office | Project area |
|---|---|---|---|
| April 4, 2019 | VAI | Center for Veterinary Medicine | Monitoring of Marketed Animal Drugs, Feed, and Devices |
| May 16, 2018 | VAI | Center for Veterinary Medicine | Monitoring of Marketed Animal Drugs, Feed, and Devices |
| December 14, 2015 | VAI | Center for Veterinary Medicine | Monitoring of Marketed Animal Drugs, Feed, and Devices |
| August 5, 2014 | NAI | Center for Veterinary Medicine | Monitoring of Marketed Animal Drugs, Feed, and Devices |
| March 31, 2010 | VAI | Center for Veterinary Medicine | Monitoring of Marketed Animal Drugs, Feed, and Devices |
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