FDA Inspection
Fortune Pharmacal Company LtdFortune Pharmacal Company Ltd – FDA Inspection, Jul 13, 2018
Record Details
This FDA Inspection record concerns Fortune Pharmacal Company Ltd, with an inspection on July 13, 2018, issued by the Center for Drug Evaluation and Research, covering drugs.
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ID · 09c133c8-d719-4a98-8391-73ac6a341ba2
Inspection Facts
Voluntary Action Indicated (VAI)
Objectionable conditions were found, but FDA is not prepared to take or recommend regulatory action.
- Inspection number
- 1059826
- FDA center
- Human Drugs
- Project area
- Drug Quality Assurance
- Outcome
- Form 483 issued
FDA Citations
5- 21 CFR 211.165(d)Acceptance criteria for sampling & testing
- 21 CFR 211.58Buildings not maintained in good state of repair
- 21 CFR 211.170(b)Annual visual exams of drug products
- 21 CFR 211.48(a)Potable water standards not met
- 21 CFR 211.110(a)Written in-process control procedures
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Other FDA inspections of Fortune Pharmacal Company Ltd
2| Date | Classification | Office | Project area |
|---|---|---|---|
| June 6, 2025 | VAI | Office of Inspections and Investigations | Drug Quality Assurance |
| August 29, 2014 | VAI | Center for Drug Evaluation and Research | Drug Quality Assurance |
Other documents for Fortune Pharmacal Company Ltd
- FDA Inspection 1274836 - 2025-06-06
- FDA Inspection 895965 - 2014-08-29
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