AAA Molybdenum Products, Inc.
Form 483 issued December 5, 2024 · Broomfield, Colorado
- Inspection
- Dec 3 – Dec 5, 2024
- Investigator
- Christopher R. Czajka
- Observations
- 6
- Pages
- 5
- FEI number
- 3003040516
In short: On December 5, 2024, FDA issued a Form 483 with 6 observations to AAA Molybdenum Products, Inc. in Broomfield, Colorado (FEI 3003040516) after an inspection that ran Dec 3 – Dec 5, 2024. The investigator was Christopher R. Czajka. Most observations concern production and facilities & equipment; the most-cited regulation is 21 CFR 211.188 (batch production and control records).
At a glance
Production and facilities & equipment account for 4 of 6 observations.
What FDA observed
Preview: the opening words of each observationDashed: section inferred by FDA Intel and checked against the regulation text
- 01
Your firm's overall policy, intentions, and approach to validation, including the validation of production processes, cleaning…
- 02
Appropriate qualification of critical equipment…
- 03
Equipment and utensils are not cleaned and stored to prevent contamination that would alter the…
- 04
Batch production records are not an accurate reproduction of the…
This inspection in context
Christopher R. Czajka
37 documents · 2015–2025
Cites FDCA 501(a)(2)(A) (insanitary conditions) more than any other section. Most of their documents are for sites in California.
The firmAAA Molybdenum Products, 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 AAA Molybdenum Products, Inc.?
FDA listed 6 observations on this Form 483, mostly about production, facilities & equipment and quality system. The most-cited regulation is 21 CFR 211.188 (batch production and control records). The opening words of each observation are shown on this page.
Who inspected AAA Molybdenum Products, Inc.?
Christopher R. Czajka is named on this Form 483, for the inspection of Dec 3 – Dec 5, 2024. Each investigator has a profile showing what they cite most.
When was AAA Molybdenum Products, Inc. inspected by FDA?
The inspection ran Dec 3 – Dec 5, 2024, and the Form 483 is dated December 5, 2024.
How do I get the full Form 483 for AAA Molybdenum Products, 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.