FDA Inspection
Constant Irwindale, Inc.Constant Irwindale, Inc. – FDA Inspection, Mar 31, 2010
Record Details
This FDA Inspection record concerns Constant Irwindale, Inc., with an inspection on March 31, 2010, issued by the Center for Veterinary Medicine, covering veterinary.
- Company
- Constant Irwindale, Inc.
- Inspection Date
- March 31, 2010
- Product Type
- Veterinary
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ID · a5b39c74-a83d-4231-aa94-9e55076f5bee
Inspection Facts
Voluntary Action Indicated (VAI)
Objectionable conditions were found, but FDA is not prepared to take or recommend regulatory action.
- Inspection number
- 656888
- FDA center
- Animal Drugs & Feeds
- Project area
- Pre-Approval Eval. of Animal Drugs and Food Additives
FDA Citations
18- 21 CFR 211.68(b)Computer control of master formula records
- 21 CFR 211.42(c)(10)(iv)Environmental Monitoring System
- 21 CFR 211.188(b)(11)Identification of persons involved, each significant step
- 21 CFR 211.84(d)(3)Testing Containers & Closures Conformity with Specs
- 21 CFR 211.25(a)Training--operations, GMPs, written procedures
- 21 CFR 211.182Specific information required in individual logs
- 21 CFR 211.84(d)(2)Reports of Analysis (Components)
- 21 CFR 211.42(c)(10)Aseptic Processing Area
- 21 CFR 211.188(b)(7)Actual yield, % of theoretical yield
- 21 CFR 211.160(b)(4)Calibration - at intervals, written program, remedial action
Showing 10 of 18 citations.
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Other FDA inspections of Constant Irwindale, Inc.
9| Date | Classification | Office | Project area |
|---|---|---|---|
| November 15, 2024 | VAI | Los Angeles District Office | Monitoring of Marketed Animal Drugs, Feeds, and Devices |
| April 25, 2019 | VAI | Center for Veterinary Medicine | Monitoring of Marketed Animal Drugs, Feed, and Devices |
| June 15, 2017 | VAI | Center for Veterinary Medicine | Monitoring of Marketed Animal Drugs, Feed, and Devices |
| September 21, 2016 | NAI | Center for Veterinary Medicine | Monitoring of Marketed Animal Drugs, Feed, and Devices |
| September 22, 2015 | NAI | Center for Veterinary Medicine | Monitoring of Marketed Animal Drugs, Feed, and Devices |
Other documents for Constant Irwindale, Inc.
- FDA Inspection 1254420 - 2024-11-15
- FDA Inspection 1092110 - 2019-04-25
- FDA Inspection 1016881 - 2017-06-15
- FDA Inspection 988844 - 2016-09-21
- FDA Inspection 943047 - 2015-09-22
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