FDA Inspection
Dalian Goodwood Medical Care LtdDalian Goodwood Medical Care Ltd – FDA Inspection, Apr 17, 2015
Record Details
This FDA Inspection record concerns Dalian Goodwood Medical Care Ltd, with an inspection on April 17, 2015, issued by the Center for Drug Evaluation and Research, covering drugs.
- Inspection Date
- April 17, 2015
- Product Type
- Drugs
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ID · d922f9d2-67a0-416a-b7f4-3530472eec7a
Inspection Facts
Voluntary Action Indicated (VAI)
Objectionable conditions were found, but FDA is not prepared to take or recommend regulatory action.
- Inspection number
- 925316
- FDA center
- Human Drugs
- Project area
- Drug Quality Assurance
FDA Citations
3- 21 CFR 211.166(a)Lack of written stability program
- 21 CFR 211.194(a)(2)Suitability of testing methods verified
- 21 CFR 211.166(a)Written program not followed
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Other FDA inspections of Dalian Goodwood Medical Care Ltd
2| Date | Classification | Office | Project area |
|---|---|---|---|
| September 20, 2018 | NAI | Center for Drug Evaluation and Research | Drug Quality Assurance |
| March 22, 2013 | NAI | Center for Drug Evaluation and Research | Drug Quality Assurance |
Other documents for Dalian Goodwood Medical Care Ltd
- FDA Inspection 1067777 - 2018-09-20
- FDA Inspection 827611 - 2013-03-22
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