AMPAC Fine Chemicals, LLC
Form 483 issued January 23, 2015 · Rancho Cordova, California
- Inspection
- Jan 20 – Jan 23, 2015
- Investigators
- Anh Luc· Ashar P. Parikh
- Observations
- 2
- Pages
- 2
- FEI number
- 2918710
In short: On January 23, 2015, FDA issued a Form 483 with 2 observations to AMPAC Fine Chemicals, LLC in Rancho Cordova, California (FEI 2918710) after an inspection that ran Jan 20 – Jan 23, 2015. The investigators were Anh Luc and Ashar P. Parikh. Most observations concern facilities & equipment and materials; the most-cited regulation is 21 CFR 211.80 (general requirements).
At a glance
Facilities & equipment and materials account for 2 of 2 observations.
Most cited: 21 CFR 211.67 (1×) · 211.80 (1×)
What FDA observed
Preview: the opening words of each observationDashed: section inferred by FDA Intel and checked against the regulation text
- 01
Your firm failed to validate the cleaning process of equipment used to manufacture multiple…
- 02
Observation 2: scanned text, readable in the full document.
This inspection in context
Anh Luc
1 document · 2015
Cites 211.67 (equipment cleaning and maintenance) more than any other section. Most of their documents are for sites in California.
The firmAMPAC Fine Chemicals, LLC history
The site's inspection history, in date order.
Similar 483sOther sites cited under 211.67
See how FDA wrote the same problem up elsewhere.
Questions about this 483
What did FDA find at AMPAC Fine Chemicals, LLC?
FDA listed 2 observations on this Form 483, mostly about facilities & equipment and materials. The most-cited regulation is 21 CFR 211.80 (general requirements). The opening words of each observation are shown on this page.
Who inspected AMPAC Fine Chemicals, LLC?
Anh Luc and Ashar P. Parikh are named on this Form 483, for the inspection of Jan 20 – Jan 23, 2015. Each investigator has a profile showing what they cite most.
When was AMPAC Fine Chemicals, LLC inspected by FDA?
The inspection ran Jan 20 – Jan 23, 2015, and the Form 483 is dated January 23, 2015.
How do I get the full Form 483 for AMPAC Fine Chemicals, 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.