FDA Inspection
SwissCo Services AGSwissCo Services AG – FDA Inspection, Sep 14, 2018
Record Details
This FDA Inspection record concerns SwissCo Services AG, with an inspection on September 14, 2018, issued by the Center for Drug Evaluation and Research, covering drugs.
- Person
- Vilmary Negron Rodriguez (Issuing Officer)
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ID · 5b0efe5f-2165-42fa-bc5c-294164491177
Inspection Facts
Voluntary Action Indicated (VAI)
Objectionable conditions were found, but FDA is not prepared to take or recommend regulatory action.
- Inspection number
- 1065533
- FDA center
- Human Drugs
- Project area
- Drug Quality Assurance
- Outcome
- Form 483 issued
FDA Citations
3- 21 CFR 211.67(b)(2)Cleaning SOPs/schedules
- 21 CFR 211.28(a)Protective Apparel Not Worn
- 21 CFR 211.100(b)SOPs not followed / documented
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Other FDA inspections of SwissCo Services AG
4| Date | Classification | Office | Project area |
|---|---|---|---|
| September 7, 2023 | NAI | Center for Drug Evaluation and Research | Drug Quality Assurance |
| December 19, 2014 | VAI | Center for Drug Evaluation and Research | Drug Quality Assurance |
| September 18, 2013 | NAI | Center for Drug Evaluation and Research | Drug Quality Assurance |
| July 8, 2011 | VAI | Center for Drug Evaluation and Research | Drug Quality Assurance |
Other documents for SwissCo Services AG
- FDA Inspection 1217120 - 2023-09-07
- FDA Inspection 907555 - 2014-12-19
- FDA Inspection 853458 - 2013-09-18
- FDA Inspection 735966 - 2011-07-08
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