Cody Laboratories, Inc.
Form 483 issued December 8, 2017 · Cody, Wyoming
- Inspection
- Dec 4 – Dec 8, 2017
- Investigators
- Christopher M. Jenner· Nayan J. Patel
- Observations
- 1
- Pages
- 2
- FEI number
- 3003149772
In short: On December 8, 2017, FDA issued a Form 483 with 1 observation to Cody Laboratories, Inc. in Cody, Wyoming (FEI 3003149772) after an inspection that ran Dec 4 – Dec 8, 2017. The investigators were Christopher M. Jenner and Nayan J. Patel. Most observations concern facilities & equipment; the most-cited regulation is 21 CFR 211.68 (automatic, mechanical, and electronic equipment).
At a glance
1 of 1 observations on this 483 concern facilities & equipment.
Most cited: 21 CFR 211.68 (1×)
What FDA observed
Preview: the opening words of each observationDashed: section inferred by FDA Intel and checked against the regulation text
- 01
Appropriate controls are not exercised over computers or related systems to assure that changes in master…
This inspection in context
Christopher M. Jenner
11 documents · 2017–2022
Cites 211.67 (equipment cleaning and maintenance) more than any other section. Most of their documents are for sites in Arizona.
The firmCody Laboratories, Inc. history
The site's inspection history, in date order.
Similar 483sOther sites cited under 211.68
See how FDA wrote the same problem up elsewhere.
Questions about this 483
What did FDA find at Cody Laboratories, Inc.?
FDA listed 1 observation on this Form 483, mostly about 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 Cody Laboratories, Inc.?
Christopher M. Jenner and Nayan J. Patel are named on this Form 483, for the inspection of Dec 4 – Dec 8, 2017. Each investigator has a profile showing what they cite most.
When was Cody Laboratories, Inc. inspected by FDA?
The inspection ran Dec 4 – Dec 8, 2017, and the Form 483 is dated December 8, 2017.
How do I get the full Form 483 for Cody Laboratories, 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.