Sigma-Aldrich Manufacturing LLC
Form 483 issued February 6, 2019 · Saint Louis, Missouri
- Inspection
- Jan 28 – Feb 6, 2019
- Investigators
- Ana P. Sandee· Robert J. Ham
- Observations
- 2
- Pages
- 2
- FEI number
- 1937990
In short: On February 6, 2019, FDA issued a Form 483 with 2 observations to Sigma-Aldrich Manufacturing LLC in Saint Louis, Missouri (FEI 1937990) after an inspection that ran Jan 28 – Feb 6, 2019. The investigators were Ana P. Sandee and Robert J. Ham. Most observations concern quality system; the most-cited regulation is 21 CFR 211.192 (production record review).
At a glance
2 of 2 observations on this 483 concern quality system.
Most cited: 21 CFR 211.192 (1×) · 211.198 (1×)
What FDA observed
Preview: the opening words of each observationDashed: section inferred by FDA Intel and checked against the regulation text
- 01
Written procedures should be established and followed for investigating critical deviations or the failure of a…
- 02
All quality-related complaints, whether received orally or in writing, should be recorded and investigated according…
This inspection in context
Ana P. Sandee
6 documents · 2019–2020
Cites 211.22 (responsibilities of quality control unit) more than any other section. Most of their documents are for sites in Missouri.
The firmSigma-Aldrich Manufacturing LLC history
All 3 documents on file for this site, in date order, with what was cited at each inspection.
Similar 483sOther sites cited under 211.192
See how FDA wrote the same problem up elsewhere.
Questions about this 483
What did FDA find at Sigma-Aldrich Manufacturing LLC?
FDA listed 2 observations on this Form 483, mostly about quality system. The most-cited regulation is 21 CFR 211.192 (production record review). The opening words of each observation are shown on this page.
Who inspected Sigma-Aldrich Manufacturing LLC?
Ana P. Sandee and Robert J. Ham are named on this Form 483, for the inspection of Jan 28 – Feb 6, 2019. Each investigator has a profile showing what they cite most.
When was Sigma-Aldrich Manufacturing LLC inspected by FDA?
The inspection ran Jan 28 – Feb 6, 2019, and the Form 483 is dated February 6, 2019.
How do I get the full Form 483 for Sigma-Aldrich Manufacturing LLC?
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.