FDA Inspection
Kari Gran Inc.Kari Gran Inc. – FDA Inspection, Jul 8, 2022
Record Details
This FDA Inspection record concerns Kari Gran Inc., with an inspection on July 8, 2022, issued by the Center for Drug Evaluation and Research, covering drugs.
- Company
- Kari Gran Inc.
- Inspection Date
- July 8, 2022
- Product Type
- Drugs
View Company Profile
ID · 7360ec03-fa79-4583-8854-51521f8bc13a
Inspection Facts
Official Action Indicated (OAI)
Significant objectionable conditions were found and regulatory or administrative action is recommended.
- Inspection number
- 1174076
- FDA center
- Human Drugs
- Project area
- Drug Quality Assurance
- Enforcement
- Warning Letter
FDA Citations
11- 21 CFR 211.165(d)Acceptance criteria for sampling & testing
- 21 CFR 211.137(d)Expiration date location on labeling
- 21 CFR 211.84(a)Components withheld from use pending release
- 21 CFR 211.165(a)Testing and release for distribution
- 21 CFR 211.188(b)Batch production and Batch Control Record Requirements
- 21 CFR 211.130(c)Lot or control number assigned
- 21 CFR 211.100(a)Absence of Written Procedures
- 21 CFR 211.166(a)Lack of written stability program
- 21 CFR 211.22(d)Procedures not in writing, fully followed
- 21 CFR 211.180(e)(2)Items to cover on annual reviews
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Other FDA inspections of Kari Gran Inc.
1| Date | Classification | Office | Project area |
|---|---|---|---|
| October 26, 2023 | NAI | Center for Drug Evaluation and Research | Drug Quality Assurance |
Other documents for Kari Gran Inc.
- FDA Inspection 1223774 - 2023-10-26
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