FDA Inspection
Surmasis Pharmaceutical, LLCSurmasis Pharmaceutical, LLC – FDA Inspection, Mar 1, 2018
Record Details
This FDA Inspection record concerns Surmasis Pharmaceutical, LLC, with an inspection on March 1, 2018, issued by the Center for Drug Evaluation and Research, covering drugs.
View Company Profile
ID · e05262f6-17af-45f8-8849-59e1059d8573
Inspection Facts
Official Action Indicated (OAI)
Significant objectionable conditions were found and regulatory or administrative action is recommended.
- Inspection number
- 1042777
- FDA center
- Human Drugs
- Project area
- Generic Drug Evaluation
- Outcome
- Form 483 issued
FDA Citations
5- 21 CFR 211.100(a)Absence of Written Procedures
- 21 CFR 211.160(b)Scientifically sound laboratory controls
- 21 CFR 211.194(a)Complete test data included in records
- 21 CFR 211.68(a)Calibration/Inspection/Checking not done
- 21 CFR 211.68(b)Computer control of master formula records
Full citation text and observation details available on the Dashboard.
Other FDA inspections of Surmasis Pharmaceutical, LLC
2| Date | Classification | Office | Project area |
|---|---|---|---|
| August 1, 2025 | VAI | Kansas City District Office | Drug Quality Assurance |
| March 19, 2020 | VAI | Center for Drug Evaluation and Research | Drug Quality Assurance |
Other documents for Surmasis Pharmaceutical, LLC
- FDA Inspection 1277270 - 2025-08-01
- FDA Inspection 1121169 - 2020-03-19
Document or profile
One record shows the event. A profile shows the pattern.
Buy this document for the source file and details behind this single event.
Choose full profile access to connect related records, sites, people, citations, and enforcement history in one view.