S&B Pharma LLC DBA Alkem Laboratories
Form 483 issued June 17, 2022 · Fenton, Missouri
- Inspection
- Jun 6 – Jun 17, 2022
- Investigator
- Logan T. Williams
- Observations
- 3
- Pages
- 5
- FEI number
- 1940750
In short: On June 17, 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 Jun 6 – Jun 17, 2022. The investigator was Logan T. Williams. Most observations concern production and facilities & equipment.
At a glance
2 of 3 observations on this 483 concern production.
What FDA observed
Preview: the opening words of each observationDashed: section inferred by FDA Intel and checked against the regulation text
- 01
Equipment used in the manufacturing, processing, packing or holding of drug products is not of appropriate…
- 02
There are inadequate written procedures for production and process control designed to assure that the drug…
- 03
In-process materials are not adequately tested for identity, strength, quality, and purity as appropriate, and approved…
This inspection in context
Logan T. Williams
32 documents · 2020–2026
Cites 211.113 (control of microbiological contamination) more than any other section. Most of their documents are for sites in Kentucky.
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 211.68
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 production and facilities & equipment. The opening words of each observation are shown on this page.
Who inspected S&B Pharma LLC DBA Alkem Laboratories?
Logan T. Williams is named on this Form 483, for the inspection of Jun 6 – Jun 17, 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 Jun 6 – Jun 17, 2022, and the Form 483 is dated June 17, 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.