Wiley Chemists, Inc.
Form 483 issued October 2, 2013 · Santa Fe, New Mexico
- Inspection
- Sep 30 – Oct 2, 2013
- Investigators
- Erika V. Butler· Michael A. Charles
- Observations
- 5
- Pages
- 2
- FEI number
- 3009792262
In short: On October 2, 2013, FDA issued a Form 483 with 5 observations to Wiley Chemists, Inc. in Santa Fe, New Mexico (FEI 3009792262) after an inspection that ran Sep 30 – Oct 2, 2013. The investigators were Erika V. Butler and Michael A. Charles. Most observations concern materials and laboratory controls.
At a glance
Materials and laboratory controls account for 3 of 5 observations.
What FDA observed
Preview: the opening words of each observationDashed: section inferred by FDA Intel and checked against the regulation text
- 01
Testing and release of drug product for distribution do not include appropriate laboratory determination of satisfactory…
- 02
The identity of each component of a drug product is not verified by conducting at least…
- 03
The distribution system is deficient in that each lot of drug product cannot be readily determined…
- 04
Routine calibration of electronic equipment is not performed according to a written program designed…
This inspection in context
Erika V. Butler
23 documents · 2007–2019
Cites 211.192 (production record review) more than any other section. Most of their documents are for sites in Colorado.
The firmWiley Chemists, Inc. history
The site's inspection history, in date order.
Similar 483sOther sites cited under 211.165
See how FDA wrote the same problem up elsewhere.
Questions about this 483
What did FDA find at Wiley Chemists, Inc.?
FDA listed 5 observations on this Form 483, mostly about materials, laboratory controls and facilities & equipment. The opening words of each observation are shown on this page.
Who inspected Wiley Chemists, Inc.?
Erika V. Butler and Michael A. Charles are named on this Form 483, for the inspection of Sep 30 – Oct 2, 2013. Each investigator has a profile showing what they cite most.
When was Wiley Chemists, Inc. inspected by FDA?
The inspection ran Sep 30 – Oct 2, 2013, and the Form 483 is dated October 2, 2013.
How do I get the full Form 483 for Wiley Chemists, 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.