Missouri Analytical Laboratories Inc
Form 483 issued May 19, 2021 · Saint Louis, Missouri
- Inspection
- May 3 – May 19, 2021
- Investigators
- Matthew Schuckmann· Wayne D. McGrath
- Observations
- 5
- Pages
- 8
- FEI number
- 1946524
In short: On May 19, 2021, FDA issued a Form 483 with 5 observations to Missouri Analytical Laboratories Inc in Saint Louis, Missouri (FEI 1946524) after an inspection that ran May 3 – May 19, 2021. The investigators were Matthew Schuckmann and Wayne D. McGrath. Most observations concern quality system and facilities & equipment.
At a glance
3 of 5 observations on this 483 concern quality system.
What FDA observed
Preview: the opening words of each observation- 01
The responsibilities and procedures applicable to the quality control unit…
- 02
There is a failure to thoroughly review any unexplained discrepancy and the failure of a batch…
- 03
Employees engaged in the manufacture and processing of a drug product lack the training required to…
- 04
Appropriate controls are not exercised over computers or related systems to assure that changes in master…
This inspection in context
Matthew Schuckmann
7 documents · 2021–2026
Cites 211.22 (responsibilities of quality control unit) more than any other section. Most of their documents are for sites in Missouri.
The firmMissouri Analytical Laboratories Inc history
All 3 documents on file for this site, in date order, with what was cited at each inspection.
Similar 483sOther sites cited under 211.22(d)
See how FDA wrote the same problem up elsewhere.
Questions about this 483
What did FDA find at Missouri Analytical Laboratories Inc?
FDA listed 5 observations on this Form 483, mostly about quality system, facilities & equipment and laboratory controls. The opening words of each observation are shown on this page.
Who inspected Missouri Analytical Laboratories Inc?
Matthew Schuckmann and Wayne D. McGrath are named on this Form 483, for the inspection of May 3 – May 19, 2021. Each investigator has a profile showing what they cite most.
When was Missouri Analytical Laboratories Inc inspected by FDA?
The inspection ran May 3 – May 19, 2021, and the Form 483 is dated May 19, 2021.
How do I get the full Form 483 for Missouri Analytical Laboratories Inc?
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.