FDA Inspection
Fill It Pack It IncFill It Pack It Inc – FDA Inspection, Nov 5, 2018
Record Details
This FDA Inspection record concerns Fill It Pack It Inc, with an inspection on November 5, 2018, issued by the Center for Drug Evaluation and Research, covering drugs.
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ID · 3ee198b7-164c-4696-b217-62e1e1290884
Inspection Facts
Official Action Indicated (OAI)
Significant objectionable conditions were found and regulatory or administrative action is recommended.
- Inspection number
- 1070999
- FDA center
- Human Drugs
- Project area
- Drug Quality Assurance
- Outcome
- Form 483 issued
- Enforcement
- Warning Letter
FDA Citations
3- 21 CFR 211.160(b)(2)Acceptance of in-process materials
- 21 CFR 211.113(b)Validation lacking for sterile drug products
- 21 CFR 211.22(d)Procedures not in writing, fully followed
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Other FDA inspections of Fill It Pack It Inc
2| Date | Classification | Office | Project area |
|---|---|---|---|
| March 15, 2021 | NAI | Center for Drug Evaluation and Research | Drug Quality Assurance |
| August 8, 2018 | VAI | Center for Drug Evaluation and Research | Drug Quality Assurance |
Other documents for Fill It Pack It Inc
- FDA Inspection 1139661 - 2021-03-15
- FDA Inspection 1061500 - 2018-08-08
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