S&B Pharma LLC DBA Alkem Laboratories
Form 483 issued June 18, 2021 · Fenton, Missouri
- Inspection
- Jun 16 – Jun 18, 2021
- Investigators
- P. Vikas Moolchandani· Ra Derrionna M. Epps
- Observations
- 2
- Pages
- 3
- FEI number
- 1940750
In short: On June 18, 2021, 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 Jun 16 – Jun 18, 2021. The investigators were P. Vikas Moolchandani and Ra Derrionna M. Epps. Most observations concern facilities & equipment and quality system; the most-cited regulation is 21 CFR 211.68 (automatic, mechanical, and electronic equipment).
At a glance
Facilities & equipment and quality system account for 2 of 2 observations.
Most cited: 21 CFR 211.68 (1×) · 211.22 (1×)
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 manufacture, processing, packing or holding of drug products is not of appropriate…
- 02
The responsibilities and procedures applicable to the quality control unit are not in…
This inspection in context
P. Vikas Moolchandani
1 document · 2021
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 211.68
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 2 observations on this Form 483, mostly about facilities & equipment and quality system. The most-cited regulation is 21 CFR 211.68 (automatic, mechanical, and electronic equipment). The opening words of each observation are shown on this page.
Who inspected S&B Pharma LLC DBA Alkem Laboratories?
P. Vikas Moolchandani and Ra Derrionna M. Epps are named on this Form 483, for the inspection of Jun 16 – Jun 18, 2021. 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 16 – Jun 18, 2021, and the Form 483 is dated June 18, 2021.
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.