FDA Inspection
Frontida BioPharm IncFrontida BioPharm Inc – FDA Inspection, Jul 17, 2015
Record Details
This FDA Inspection record concerns Frontida BioPharm Inc, with an inspection on July 17, 2015, issued by the Center for Drug Evaluation and Research, covering drugs.
- Company
- Frontida BioPharm Inc
- Inspection Date
- July 17, 2015
- Product Type
- Drugs
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ID · 2cf91318-6f6b-4647-a138-7593f304329e
Inspection Facts
Official Action Indicated (OAI)
Significant objectionable conditions were found and regulatory or administrative action is recommended.
- Inspection number
- 936055
- FDA center
- Human Drugs
- Project area
- Drug Quality Assurance
FDA Citations
10- 21 CFR 314.81(b)(1)(i)Mix-up
- 21 CFR 314.81(b)(1)(ii)Contamination, chemical or physical change, deterioration
- 21 CFR 211.165(f)Failing drug products not rejected
- 21 CFR 211.194(a)(1)Sample identification and other information
- 21 CFR 211.150(b)Distribution Recall System
- 21 CFR 211.100(a)Absence of Written Procedures
- 21 CFR 211.192Investigations of discrepancies, failures
- 21 CFR 211.22(d)Procedures not in writing, fully followed
- 21 CFR 211.166(a)Written program not followed
- 21 CFR 211.67(b)Written procedures not established/followed
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Other FDA inspections of Frontida BioPharm Inc
14| Date | Classification | Office | Project area |
|---|---|---|---|
| April 2, 2026 | Not classified | Philadelphia District Office | |
| July 22, 2025 | NAI | Center for Tobacco Products | Tobacco Post-Market Activities |
| July 22, 2025 | NAI | Center for Tobacco Products | Tobacco Post-Market Activities |
| December 7, 2023 | VAI | Center for Drug Evaluation and Research | Drug Quality Assurance |
| July 19, 2019 | VAI | Center for Drug Evaluation and Research | Drug Quality Assurance |
Other documents for Frontida BioPharm Inc
- FDA Inspection 1316756 - 2026-04-02
- FDA Inspection 1280570 - 2025-07-22
- FDA Inspection 1279864 - 2025-07-22
- FDA Inspection 1226606 - 2023-12-07
- FDA Inspection 1097023 - 2019-07-19
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