FDA Inspection
Accupac, LLCAccupac, LLC – FDA Inspection, Nov 2, 2017
Record Details
This FDA Inspection record concerns Accupac, LLC, with an inspection on November 2, 2017, issued by the Center for Drug Evaluation and Research, covering drugs.
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ID · fd419061-07d8-4e57-aba1-a4307fcafd33
Inspection Facts
Voluntary Action Indicated (VAI)
Objectionable conditions were found, but FDA is not prepared to take or recommend regulatory action.
- Inspection number
- 1030873
- FDA center
- Human Drugs
- Project area
- Drug Quality Assurance
- Outcome
- Form 483 issued
FDA Citations
5- 21 CFR 211.22(b)Adequate lab facilities not available
- 21 CFR 211.68(b)Computer control of master formula records
- 21 CFR 211.58Buildings not maintained in good state of repair
- 21 CFR 211.67(a)Cleaning / Sanitizing / Maintenance
- 21 CFR 211.67(b)(5)Cleaning SOPs/equipment protection
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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 |
| 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 |
| May 22, 2009 | VAI | Center for Drug Evaluation and Research | Drug Quality Assurance |
Other documents for Accupac, LLC
- FDA Inspection 1196516 - 2023-01-24
- FDA Inspection 986007 - 2016-03-31
- FDA Inspection 844740 - 2013-07-19
- FDA Inspection 589456 - 2009-05-22
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