S&B Pharma LLC DBA Alkem Laboratories
Form 483 issued February 6, 2020 · Fenton, Missouri
- Observations
- 3
- Pages
- 4
- FEI number
- 1940750
In short: On February 6, 2020, FDA issued a Form 483 with 3 observations to S&B Pharma LLC DBA Alkem Laboratories in Fenton, Missouri (FEI 1940750). Most observations concern quality system and laboratory controls.
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
Written records of investigations into the failure of a batch or any of its components to…
- 02
Laboratory controls do not include the establishment of scientifically sound and appropriate sampling plans and test…
- 03
Records are not maintained so that data therein can be reviewed at least annually to evaluate…
This inspection in context
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 laboratory controls. The opening words of each observation are shown on this page.
When was S&B Pharma LLC DBA Alkem Laboratories inspected by FDA?
This Form 483 is dated February 6, 2020.
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.