FDA Inspection
Guilin Pharmaceutical Co., Ltd.Guilin Pharmaceutical Co., Ltd. – FDA Inspection, Aug 18, 2023
Record Details
This FDA Inspection record concerns Guilin Pharmaceutical Co., Ltd., with an inspection on August 18, 2023, issued by the Center for Drug Evaluation and Research, covering drugs.
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ID · 330fef8b-c36c-41fe-beb1-3e7344d42db6
Inspection Facts
No Action Indicated (NAI)
No objectionable conditions or practices were found during the inspection.
- Inspection number
- 1217732
- FDA center
- Human Drugs
- Project area
- Drug Quality Assurance
- Outcome
- Form 483 issued
FDA Citations
4- 21 CFR 211.22(d)Procedures not in writing, fully followed
- 21 CFR 211.56(a)Sanitation--buildings not clean, free of infestation
- 21 CFR 211.63Equipment Design, Size and Location
- 21 CFR 211.68(b)Computer control of master formula records
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Other FDA inspections of Guilin Pharmaceutical Co., Ltd.
3| Date | Classification | Office | Project area |
|---|---|---|---|
| July 19, 2018 | VAI | Center for Drug Evaluation and Research | Drug Quality Assurance |
| March 13, 2015 | VAI | Center for Drug Evaluation and Research | Drug Quality Assurance |
| September 2, 2011 | VAI | Center for Drug Evaluation and Research | Drug Quality Assurance |
Other documents for Guilin Pharmaceutical Co., Ltd.
- FDA Inspection 1061489 - 2018-07-19
- FDA Inspection 920262 - 2015-03-13
- FDA Inspection 748950 - 2011-09-02
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