S&B Pharma LLC DBA Alkem Laboratories
Form 483 issued February 5, 2019 · Fenton, Missouri
- Inspection
- Jan 14 – Feb 5, 2019
- Observations
- 8
- Pages
- 13
- FEI number
- 1940750
In short: On February 5, 2019, FDA issued a Form 483 with 8 observations to S&B Pharma LLC DBA Alkem Laboratories in Fenton, Missouri (FEI 1940750) after an inspection that ran Jan 14 – Feb 5, 2019. Most observations concern quality system and laboratory controls; the most-cited regulation is 21 CFR 211.22 (responsibilities of quality control unit).
At a glance
Observations span 4 systems, led by quality system.
Most cited: 21 CFR 211.22 (2×)
What FDA observed
Preview: the opening words of each observationDashed: section inferred by FDA Intel and checked against the regulation text
- 01
The quality control unit lacks the responsibility and authority to approve and reject all components, drug…
- 02
Laboratory records do not include complete data derived from all tests, examinations and assay necessary to…
- 03
Written production and process control procedures are not followed in the execution of production and. process…
- 04
Input to and output from the computer, related systems of formulas and records or data are…
This inspection in context
Questions about this 483
What did FDA find at S&B Pharma LLC DBA Alkem Laboratories?
FDA listed 8 observations on this Form 483, mostly about quality system, laboratory controls and facilities & equipment. The most-cited regulation is 21 CFR 211.22 (responsibilities of quality control unit). The opening words of each observation are shown on this page.
When was S&B Pharma LLC DBA Alkem Laboratories inspected by FDA?
The inspection ran Jan 14 – Feb 5, 2019, and the Form 483 is dated February 5, 2019.
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.