FDA Inspection
Hobe Laboratories Inc.Hobe Laboratories Inc. – FDA Inspection, Apr 20, 2018
Record Details
This FDA Inspection record concerns Hobe Laboratories Inc., with an inspection on April 20, 2018, issued by the Center for Veterinary Medicine, covering veterinary.
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ID · f9c854eb-48a2-4cb9-9645-2d4614224d51
Inspection Facts
Voluntary Action Indicated (VAI)
Objectionable conditions were found, but FDA is not prepared to take or recommend regulatory action.
- Inspection number
- 1049182
- FDA center
- Animal Drugs & Feeds
- Project area
- Monitoring of Marketed Animal Drugs, Feed, and Devices
- Outcome
- Form 483 issued
FDA Citations
8- 21 CFR 211.188Prepared for each batch, include complete information
- 21 CFR 211.110(a)Control procedures to monitor and validate performance
- 21 CFR 211.84(a)Components withheld from use pending release
- 21 CFR 211.25(a)GMP Training Frequency
- 21 CFR 211.68(a)Written calibration / inspection records not kept
- 21 CFR 211.105(b)Distinctive ID or code not recorded in batch record
- 21 CFR 211.84(d)(1)Identity Testing of Each Component
- 21 CFR 211.182Written records kept in individual logs
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Other FDA inspections of Hobe Laboratories Inc.
4| Date | Classification | Office | Project area |
|---|---|---|---|
| April 13, 2026 | Not classified | Denver District Office | |
| June 12, 2018 | VAI | Center for Food Safety and Applied Nutrition | Food Composition, Standards, Labeling and Econ |
| January 21, 2011 | NAI | Center for Drug Evaluation and Research | Drug Quality Assurance |
| February 19, 2010 | NAI | Center for Drug Evaluation and Research | Drug Quality Assurance |
Other documents for Hobe Laboratories Inc.
- FDA Inspection 1316028 - 2026-04-13
- FDA Inspection 1055293 - 2018-06-12
- FDA Inspection 706658 - 2011-01-21
- FDA Inspection 647464 - 2010-02-19
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