FDA Inspection
Accupac, LLCAccupac, LLC – FDA Inspection, May 22, 2009
Record Details
This FDA Inspection record concerns Accupac, LLC, with an inspection on May 22, 2009, issued by the Center for Drug Evaluation and Research, covering drugs.
- Company
- Accupac, LLC
- Inspection Date
- May 22, 2009
- Product Type
- Drugs
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ID · 70273dee-1bea-47c0-84f9-c482a44ba54e
Inspection Facts
Voluntary Action Indicated (VAI)
Objectionable conditions were found, but FDA is not prepared to take or recommend regulatory action.
- Inspection number
- 589456
- FDA center
- Human Drugs
- Project area
- Drug Quality Assurance
FDA Citations
5- 21 CFR 211.100(a)Changes to Procedures Not Reviewed, Approved
- 21 CFR 211.182Personnel dating/signing equipment log
- 21 CFR 211.22(d)Procedures not in writing, fully followed
- 21 CFR 211.67(b)Written procedures fail to include
- 21 CFR 211.100(b)SOPs not followed / documented
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Other FDA inspections of Accupac, LLC
4| Date | Classification | Office | Project area |
|---|---|---|---|
| January 24, 2023 | NAI | Center for Drug Evaluation and Research | Drug Quality Assurance |
| November 2, 2017 | VAI | Center for Drug Evaluation and Research | Drug Quality Assurance |
| March 31, 2016 | VAI | Center for Veterinary Medicine | Monitoring of Marketed Animal Drugs, Feed, and Devices |
| July 19, 2013 | NAI | Center for Devices and Radiological Health | Compliance: Devices |
Other documents for Accupac, LLC
- FDA Inspection 1196516 - 2023-01-24
- FDA Inspection 1030873 - 2017-11-02
- FDA Inspection 986007 - 2016-03-31
- FDA Inspection 844740 - 2013-07-19
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