FDA Inspection
Laclede, Inc.Laclede, Inc. – FDA Inspection, Nov 7, 2018
Record Details
This FDA Inspection record concerns Laclede, Inc., with an inspection on November 7, 2018, issued by the Los Angeles District Office, covering animal drugs & feeds.
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ID · dc8ca59c-bf95-4cd1-a954-05afcc2a567c
Inspection Facts
- Inspection number
- 1071099
- FDA center
- Animal Drugs & Feeds
- Project area
- Monitoring of Marketed Animal Drugs, Feed, and Devices
- Outcome
- Form 483 issued
FDA Citations
8- 21 CFR 211.160(b)Scientifically sound laboratory controls
- 21 CFR 211.165(a)Testing and release for distribution
- 21 CFR 211.194(a)(4)Data secured in course of each test
- 21 CFR 211.68(b)Computer control of master formula records
- 21 CFR 211.87Retest of approved components/containers/closures
- 21 CFR 820.30(a)Design control - no procedures
- 21 CFR 820.30(g)Design Validation - Risk analysis not performed/inadequate
- 21 CFR 820.30(j)Design history file
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Other FDA inspections of Laclede, Inc.
4| Date | Classification | Office | Project area |
|---|---|---|---|
| September 4, 2013 | OAI | Center for Drug Evaluation and Research | Unapproved and Misbranded Drugs |
| June 27, 2012 | OAI | Center for Drug Evaluation and Research | Drug Quality Assurance |
| July 13, 2011 | VAI | Center for Drug Evaluation and Research | Unapproved and Misbranded Drugs |
| September 10, 2010 | NAI | Center for Veterinary Medicine | Monitoring of Marketed Animal Drugs, Feed, and Devices |
Other documents for Laclede, Inc.
- FDA Inspection 848328 - 2013-09-04
- FDA Inspection 788585 - 2012-06-27
- FDA Inspection 737009 - 2011-07-13
- FDA Inspection 681079 - 2010-09-10
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