FDA Inspection
Surmasis Pharmaceutical, LLCSurmasis Pharmaceutical, LLC – FDA Inspection, Aug 1, 2025
Record Details
This FDA Inspection record concerns Surmasis Pharmaceutical, LLC, with an inspection on August 1, 2025, issued by the Kansas City District Office, covering human drugs.
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ID · 5fb29e39-e823-41b8-9d3c-db716adf874c
Inspection Facts
Voluntary Action Indicated (VAI)
Objectionable conditions were found, but FDA is not prepared to take or recommend regulatory action.
- Inspection number
- 1277270
- FDA center
- Human Drugs
- Project area
- Drug Quality Assurance
FDA Citations
4- 21 CFR 820.20(d)Quality plan
- 21 CFR 820.20(c)Management review - defined interval, sufficient frequency
- 21 CFR 211.22(d)Procedures not in writing, fully followed
- 21 CFR 211.192No written record of investigation
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Other FDA inspections of Surmasis Pharmaceutical, LLC
2| Date | Classification | Office | Project area |
|---|---|---|---|
| March 19, 2020 | VAI | Center for Drug Evaluation and Research | Drug Quality Assurance |
| March 1, 2018 | OAI | Center for Drug Evaluation and Research | Generic Drug Evaluation |
Other documents for Surmasis Pharmaceutical, LLC
- FDA Inspection 1121169 - 2020-03-19
- FDA Inspection 1042777 - 2018-03-01
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