S&B Pharma LLC DBA Alkem Laboratories
Form 483 issued September 14, 2022 · Fenton, Missouri
- Inspection
- Sep 6 – Sep 14, 2022
- Investigator
- Matthew Schuckmann
- Observations
- 2
- Pages
- 3
- FEI number
- 1940750
In short: On September 14, 2022, FDA issued a Form 483 with 2 observations to S&B Pharma LLC DBA Alkem Laboratories in Fenton, Missouri (FEI 1940750) after an inspection that ran Sep 6 – Sep 14, 2022. The investigator was Matthew Schuckmann. Most observations concern production; the most-cited regulation is 21 CFR 211.110 (sampling and testing of in-process materials and drug products).
At a glance
2 of 2 observations on this 483 concern production.
Most cited: 21 CFR 211.110 (1×) · 211.113 (1×)
What FDA observed
Preview: the opening words of each observationDashed: section inferred by FDA Intel and checked against the regulation text
- 01
Written procedures were not established and followed that describe the in-process controls, and tests, or examinations…
- 02
Procedures designed to prevent objectionable microorganisms in drug products not required to be sterile are not…
This inspection in context
Matthew Schuckmann
7 documents · 2021–2026
Cites 211.22 (responsibilities of quality control unit) more than any other section. Most of their documents are for sites in Missouri.
The firmS&B Pharma LLC DBA Alkem Laboratories history
All 6 documents on file for this site, in date order, with what was cited at each inspection.
Similar 483sOther sites cited under 211.110
See how FDA wrote the same problem up elsewhere.
Questions about this 483
What did FDA find at S&B Pharma LLC DBA Alkem Laboratories?
FDA listed 2 observations on this Form 483, mostly about production. The most-cited regulation is 21 CFR 211.110 (sampling and testing of in-process materials and drug products). The opening words of each observation are shown on this page.
Who inspected S&B Pharma LLC DBA Alkem Laboratories?
Matthew Schuckmann is named on this Form 483, for the inspection of Sep 6 – Sep 14, 2022. Each investigator has a profile showing what they cite most.
When was S&B Pharma LLC DBA Alkem Laboratories inspected by FDA?
The inspection ran Sep 6 – Sep 14, 2022, and the Form 483 is dated September 14, 2022.
How do I get the full Form 483 for S&B Pharma LLC DBA Alkem Laboratories?
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