FDA Inspection
Piramal Critical Care, Inc.Piramal Critical Care, Inc. – FDA Inspection, Sep 27, 2023
Record Details
This FDA Inspection record concerns Piramal Critical Care, Inc., with an inspection on September 27, 2023, issued by the Center for Veterinary Medicine, covering veterinary.
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ID · 75429efc-a95f-43cc-91bf-a319ee695b96
Inspection Facts
Voluntary Action Indicated (VAI)
Objectionable conditions were found, but FDA is not prepared to take or recommend regulatory action.
- Inspection number
- 1218865
- FDA center
- Animal Drugs & Feeds
- Project area
- Monitoring of Marketed Animal Drugs, Feed, and Devices
- Outcome
- Form 483 issued
FDA Citations
4- 21 CFR 211.67(c)Cleaning/maintenance records not kept
- 21 CFR 211.100(a)Absence of Written Procedures
- 21 CFR 211.100(a)Absence of Written Procedures
- 21 CFR 211.67(c)Cleaning/maintenance records not kept
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Other FDA inspections of Piramal Critical Care, Inc.
8| Date | Classification | Office | Project area |
|---|---|---|---|
| May 7, 2019 | NAI | Center for Drug Evaluation and Research | Drug Quality Assurance |
| July 19, 2018 | Not classified | Philadelphia District Office | |
| September 22, 2017 | VAI | Center for Drug Evaluation and Research | Drug Quality Assurance |
| October 31, 2014 | VAI | Center for Veterinary Medicine | Monitoring of Marketed Animal Drugs, Feed, and Devices |
| July 26, 2013 | VAI | Center for Drug Evaluation and Research | Drug Quality Assurance |
Other documents for Piramal Critical Care, Inc.
- FDA Inspection 1091231 - 2019-05-07
- FDA Inspection 1136915 - 2018-07-19
- FDA Inspection 1030647 - 2017-09-22
- FDA Inspection 904540 - 2014-10-31
- FDA Inspection 842131 - 2013-07-26
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