FDA Inspection
Fill It Pack It IncFill It Pack It Inc – FDA Inspection, Aug 8, 2018
Record Details
This FDA Inspection record concerns Fill It Pack It Inc, with an inspection on August 8, 2018, issued by the Center for Drug Evaluation and Research, covering drugs.
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ID · 08baa013-43f1-4a71-a722-e10d1d7ef9b6
Inspection Facts
Voluntary Action Indicated (VAI)
Objectionable conditions were found, but FDA is not prepared to take or recommend regulatory action.
- Inspection number
- 1061500
- FDA center
- Human Drugs
- Project area
- Drug Quality Assurance
- Outcome
- Form 483 issued
FDA Citations
7- 21 CFR 211.105(a)Identification of containers, lines, equipment
- 21 CFR 211.25(a)GMP Training Frequency
- 21 CFR 211.42(c)(10)Aseptic Processing Area
- 21 CFR 211.188(a)Accurate reproduction
- 21 CFR 211.22(d)Procedures not in writing, fully followed
- 21 CFR 211.42(c)Defined areas of adequate size for operations
- 21 CFR 211.111Establishment of time limitations
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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 |
| November 5, 2018 | OAI | 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 1070999 - 2018-11-05
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