S&B Pharma LLC DBA Alkem Laboratories
FDA inspection history in Fenton, Missouri, 2019 to 2022
- 6
- Form 483s
Every document, by year
- Form 483
2019: one Form 483; 2020: one Form 483; 2021: one Form 483; 2022: three Form 483s.
The story so far
Built from the dates and citations on the documents themselves.
- 2019–22Six Form 483s, at Fenton, Missouri.
- 2019The longest 483 on file: 8 observations over 13 pages at Fenton, Missouri.
Cited most
Across all S&B Pharma LLC DBA Alkem Laboratories observations on file
- 21 CFR 211.22Responsibilities of quality control unit4
- 21 CFR 211.192Production record review3
- 21 CFR 211.68Automatic, mechanical, and electronic equipment3
- 21 CFR 211.100Written procedures; deviations2
- 21 CFR 211.110Sampling and testing of in-process materials and drug products2
The complete S&B Pharma LLC DBA Alkem Laboratories file.
All 6 documents as original PDFs, in one order. For supplier audits, diligence and inspection prep.
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Sites
Fenton, Missouri
Six Form 483s · 2019 to 2022 · 16 observations
Latest: Form 483, Nov 8, 2022 →
Documents
6 on file, newest first| Date | Document | Location | Observations | Price |
|---|---|---|---|---|
| 2022-11-08 | 483 Form 483 | Fenton, Missouri | 3 | $99 |
| 2022-09-14 | 483 Form 483 | Fenton, Missouri | — | $99 |
| 2022-06-17 | 483 Form 483 | Fenton, Missouri | — | $99 |
| 2021-06-18 | 483 Form 483 | Fenton, Missouri | 2 | $99 |
| 2020-02-06 | 483 Form 483 | Fenton, Missouri | 3 | $99 |
| 2019-02-05 | 483 Form 483 | Fenton, Missouri | 8 | $99 |
Investigators on these documents
Logan T. Williams (1)Matthew Schuckmann (1)Monica E. Murie (1)P. Vikas Moolchandani (1)Ra Derrionna M. Epps (1)
FEI number 1940750 · most recent document Nov 8, 2022
About S&B Pharma LLC DBA Alkem Laboratories
How many FDA Form 483s has S&B Pharma LLC DBA Alkem Laboratories received?
FDA Intel has 6 Form 483s on file for S&B Pharma LLC DBA Alkem Laboratories; the most recent is dated Nov 8, 2022.
When was S&B Pharma LLC DBA Alkem Laboratories last inspected by FDA?
The most recent FDA inspection document on file for S&B Pharma LLC DBA Alkem Laboratories is a Form 483 dated Nov 8, 2022, for the site in Fenton, Missouri.
What did FDA cite at S&B Pharma LLC DBA Alkem Laboratories?
The regulations cited most in the observations on file for S&B Pharma LLC DBA Alkem Laboratories are 21 CFR 211.22 (Responsibilities of quality control unit), 4 times; 21 CFR 211.192 (Production record review), 3 times; 21 CFR 211.68 (Automatic, mechanical, and electronic equipment), 3 times.