FDA Inspection
Lotus Pharmaceutical Co., Ltd.Lotus Pharmaceutical Co., Ltd. – FDA Inspection, Sep 22, 2017
Record Details
This FDA Inspection record concerns Lotus Pharmaceutical Co., Ltd., with an inspection on September 22, 2017, issued by the Center for Drug Evaluation and Research, covering drugs.
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ID · c9a55bfd-d912-4152-91fb-6814241d953d
Inspection Facts
Voluntary Action Indicated (VAI)
Objectionable conditions were found, but FDA is not prepared to take or recommend regulatory action.
- Inspection number
- 1028353
- FDA center
- Human Drugs
- Project area
- Drug Quality Assurance
- Outcome
- Form 483 issued
FDA Citations
3- 21 CFR 211.170(b)Annual visual exams of drug products
- 21 CFR 211.160(b)(3)Drug products - samples representative, identified properly
- 21 CFR 211.192Investigations of discrepancies, failures
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Other FDA inspections of Lotus Pharmaceutical Co., Ltd.
5| Date | Classification | Office | Project area |
|---|---|---|---|
| April 12, 2024 | VAI | Center for Drug Evaluation and Research | Drug Quality Assurance |
| May 31, 2019 | NAI | Center for Drug Evaluation and Research | Drug Quality Assurance |
| June 4, 2015 | VAI | Center for Drug Evaluation and Research | Drug Quality Assurance |
| August 16, 2012 | NAI | Center for Drug Evaluation and Research | Drug Quality Assurance |
| February 11, 2010 | VAI | Center for Drug Evaluation and Research | Drug Quality Assurance |
Other documents for Lotus Pharmaceutical Co., Ltd.
- FDA Inspection 1236763 - 2024-04-12
- FDA Inspection 1095930 - 2019-05-31
- FDA Inspection 933276 - 2015-06-04
- FDA Inspection 797095 - 2012-08-16
- FDA Inspection 655757 - 2010-02-11
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