FDA Inspection
Advance Pharmaceutical IncAdvance Pharmaceutical Inc – FDA Inspection, Jul 2, 2013
Record Details
This FDA Inspection record concerns Advance Pharmaceutical Inc, with an inspection on July 2, 2013, issued by the Center for Drug Evaluation and Research, covering drugs.
- Company
- Advance Pharmaceutical Inc
- Inspection Date
- July 2, 2013
- Product Type
- Drugs
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ID · 222b8d78-02e3-4836-a86f-450f54671526
Inspection Facts
Official Action Indicated (OAI)
Significant objectionable conditions were found and regulatory or administrative action is recommended.
- Inspection number
- 841046
- FDA center
- Human Drugs
- Project area
- Drug Quality Assurance
FDA Citations
7- 21 CFR 211.198(b)(2)Complaint Investigation/Follow-Up Findings
- 21 CFR 211.160(b)Scientifically sound laboratory controls
- 21 CFR 211.125(f)Procedures Written and Followed
- 21 CFR 211.160(b)(4)Establishment of calibration procedures
- 21 CFR 211.100(a)Absence of Written Procedures
- 21 CFR 211.22(d)Procedures not in writing, fully followed
- 21 CFR 211.100(b)SOPs not followed / documented
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Other FDA inspections of Advance Pharmaceutical Inc
11| Date | Classification | Office | Project area |
|---|---|---|---|
| February 27, 2025 | VAI | New York District Office | Drug Quality Assurance |
| December 13, 2018 | VAI | Center for Drug Evaluation and Research | Drug Quality Assurance |
| July 6, 2017 | VAI | Center for Veterinary Medicine | Monitoring of Marketed Animal Drugs, Feed, and Devices |
| December 2, 2015 | OAI | Center for Drug Evaluation and Research | Drug Quality Assurance |
| March 6, 2015 | VAI | Center for Drug Evaluation and Research | Drug Quality Assurance |
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