FDA Inspection
Paket CorpPaket Corp – FDA Inspection, Aug 6, 2019
Record Details
This FDA Inspection record concerns Paket Corp, with an inspection on August 6, 2019, issued by the Center for Drug Evaluation and Research, covering drugs.
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ID · bb958312-995c-428e-ac34-ed5320a7fe74
Inspection Facts
Voluntary Action Indicated (VAI)
Objectionable conditions were found, but FDA is not prepared to take or recommend regulatory action.
- Inspection number
- 1098750
- FDA center
- Human Drugs
- Project area
- Drug Quality Assurance
- Outcome
- Form 483 issued
FDA Citations
5- 21 CFR 211.150(b)Recall facilitation
- 21 CFR 211.186(a)Master production and control records, procedure
- 21 CFR 211.22(d)Procedures not in writing, fully followed
- 21 CFR 211.67(b)Written procedures fail to include
- 21 CFR 211.100(b)SOPs not followed / documented
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Other FDA inspections of Paket Corp
2| Date | Classification | Office | Project area |
|---|---|---|---|
| April 10, 2025 | VAI | Chicago District Office | Drug Quality Assurance |
| March 31, 2017 | Not classified | Chicago District Office |
Other documents for Paket Corp
- FDA Inspection 1266580 - 2025-04-10
- FDA Inspection 1005578 - 2017-03-31
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