FDA Inspection
S&B Pharma LLCS&B Pharma LLC – FDA Inspection, Feb 5, 2019
Record Details
This FDA Inspection record concerns S&B Pharma LLC, with an inspection on February 5, 2019, issued by the Kansas City District Office, covering human drugs.
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ID · 636a1ff3-2f57-4421-b804-895b6916ba04
Inspection Facts
- Inspection number
- 1078320
- FDA center
- Human Drugs
- Project area
- Generic Drug Evaluation
- Outcome
- Form 483 issued
FDA Citations
8- 21 CFR 211.100(b)SOPs not followed / documented
- 21 CFR 211.160(b)Scientifically sound laboratory controls
- 21 CFR 211.194(a)Complete test data included in records
- 21 CFR 211.22(a)Approve or reject components, products
- 21 CFR 211.22(d)Procedures not in writing, fully followed
- 21 CFR 211.67(b)(2)Cleaning SOPs/schedules
- 21 CFR 211.68(b)input/output verification
- 21 CFR 314.81(b)(1)(ii)Failure to meet specifications
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Other FDA inspections of S&B Pharma LLC
9| Date | Classification | Office | Project area |
|---|---|---|---|
| June 17, 2022 | VAI | Center for Drug Evaluation and Research | Drug Quality Assurance |
| February 6, 2020 | VAI | Center for Drug Evaluation and Research | Drug Quality Assurance |
| March 16, 2018 | VAI | Center for Drug Evaluation and Research | Bioresearch Monitoring |
| October 27, 2017 | NAI | Center for Drug Evaluation and Research | Drug Quality Assurance |
| February 26, 2015 | VAI | Center for Drug Evaluation and Research | Drug Quality Assurance |
Other documents for S&B Pharma LLC
- FDA Inspection 1172319 - 2022-06-17
- FDA Inspection 1121238 - 2020-02-06
- FDA Inspection 1047928 - 2018-03-16
- FDA Inspection 1031001 - 2017-10-27
- FDA Inspection 915801 - 2015-02-26
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