Zoetis LLC
Form 483 issued May 3, 2021 · Kalamazoo, Michigan
- Inspection
- Apr 12 – May 3, 2021
- Investigators
- Franklin D. Heisler· Peng Zhou
- Observations
- 7
- Pages
- 15
- FEI number
- 3010146372
In short: On May 3, 2021, FDA issued a Form 483 with 7 observations to Zoetis LLC in Kalamazoo, Michigan (FEI 3010146372) after an inspection that ran Apr 12 – May 3, 2021. The investigators were Franklin D. Heisler and Peng Zhou. Most observations concern facilities & equipment and production; the most-cited regulation is 21 CFR 211.42 (design and construction features).
At a glance
Facilities & equipment and production account for 5 of 7 observations.
What FDA observed
Preview: the opening words of each observation- 01
Aseptic processing areas are deficient regarding the system…
- 02
Aseptic processing areas are deficient regarding the system for cleaning and disinfecting the room and equipment…
- 03
Procedures designed to prevent microbiological contamination of drug products purporting to be sterile are…
- 04
The quality control unit lacks authority to fully investigate…
This inspection in context
Franklin D. Heisler
1 document · 2021
Cites 211.22(a) (responsibilities of quality control unit) more than any other section. Most of their documents are for sites in Michigan.
The firmZoetis LLC history
The site's inspection history, in date order.
Similar 483sOther sites cited under 211.42(c)(10)(iv)
See how FDA wrote the same problem up elsewhere.
Questions about this 483
What did FDA find at Zoetis LLC?
FDA listed 7 observations on this Form 483, mostly about facilities & equipment, production and quality system. The most-cited regulation is 21 CFR 211.42 (design and construction features). The opening words of each observation are shown on this page.
Who inspected Zoetis LLC?
Franklin D. Heisler and Peng Zhou are named on this Form 483, for the inspection of Apr 12 – May 3, 2021. Each investigator has a profile showing what they cite most.
When was Zoetis LLC inspected by FDA?
The inspection ran Apr 12 – May 3, 2021, and the Form 483 is dated May 3, 2021.
How do I get the full Form 483 for Zoetis 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.