J.M. Huber Micropowders, Inc.
Form 483 issued June 25, 2021 · La Mirada, California
- Inspection
- Jun 22 – Jun 25, 2021
- Investigator
- Bryan A. Galvez
- Observations
- 4
- Pages
- 3
- FEI number
- 3003665718
In short: On June 25, 2021, FDA issued a Form 483 with 4 observations to J.M. Huber Micropowders, Inc. in La Mirada, California (FEI 3003665718) after an inspection that ran Jun 22 – Jun 25, 2021. The investigator was Bryan A. Galvez. Most observations concern production and facilities & equipment; the most-cited regulation is 21 CFR 211.68 (automatic, mechanical, and electronic equipment).
At a glance
Production and facilities & equipment account for 4 of 4 observations.
Most cited: 21 CFR 211.100 (2×) · 211.68 (2×)
What FDA observed
Preview: the opening words of each observationDashed: section inferred by FDA Intel and checked against the regulation text
- 01
Your firm has produced batches using processes…
- 02
Your firm failed to document all…
- 03
Your firm has not calibrated all equipment critical for ensuring…
- 04
Your firm has failed for validate…
This inspection in context
Bryan A. Galvez
15 documents · 2018–2026
Cites 211.192 (production record review) more than any other section. Most of their documents are for sites in California.
The firmJ.M. Huber Micropowders, Inc. history
The site's inspection history, in date order.
Similar 483sOther sites cited under 211.100
See how FDA wrote the same problem up elsewhere.
Questions about this 483
What did FDA find at J.M. Huber Micropowders, Inc.?
FDA listed 4 observations on this Form 483, mostly about production and facilities & equipment. 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 J.M. Huber Micropowders, Inc.?
Bryan A. Galvez is named on this Form 483, for the inspection of Jun 22 – Jun 25, 2021. Each investigator has a profile showing what they cite most.
When was J.M. Huber Micropowders, Inc. inspected by FDA?
The inspection ran Jun 22 – Jun 25, 2021, and the Form 483 is dated June 25, 2021.
How do I get the full Form 483 for J.M. Huber Micropowders, 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.