S&B Pharma LLC DBA Alkem Laboratories
Form 483 issued November 8, 2022 · Fenton, Missouri
- Inspection
- Oct 31 – Nov 8, 2022
- Investigator
- Monica E. Murie
- Observations
- 3
- Pages
- 4
- FEI number
- 1940750
In short: On November 8, 2022, FDA issued a Form 483 with 3 observations to S&B Pharma LLC DBA Alkem Laboratories in Fenton, Missouri (FEI 1940750) after an inspection that ran Oct 31 – Nov 8, 2022. The investigator was Monica E. Murie. Most observations concern quality system and production.
At a glance
2 of 3 observations on this 483 concern quality system.
What FDA observed
Preview: the opening words of each observationDashed: section inferred by FDA Intel and checked against the regulation text
- 01
There is a failure to thoroughly review any unexplained discrepancy and the failure of a batch…
- 02
The responsibilities and procedures applicable to the quality control unit…
- 03
Procedures designed to prevent objectionable microorganisms in drug products not required to be sterile are…
This inspection in context
Monica E. Murie
11 documents · 2022–2025
Cites 211.113 (control of microbiological contamination) 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 211.192
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 3 observations on this Form 483, mostly about quality system and production. The opening words of each observation are shown on this page.
Who inspected S&B Pharma LLC DBA Alkem Laboratories?
Monica E. Murie is named on this Form 483, for the inspection of Oct 31 – Nov 8, 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 Oct 31 – Nov 8, 2022, and the Form 483 is dated November 8, 2022.
How do I get the full Form 483 for S&B Pharma LLC DBA Alkem Laboratories?
Download the original PDF from FDA Intel for $99, with no subscription. Your first Form 483 or letter is on us. You also get an invoice PDF with the order.