Kendrick Laboratories
Form 483 issued March 10, 2020 · Madison, Wisconsin
- Inspection
- Mar 9 – Mar 10, 2020
- Investigators
- Lori B. Wikstrom· Sandra A. Boyd
- Observations
- 2
- Pages
- 3
- FEI number
- 3001238747
In short: On March 10, 2020, FDA issued a Form 483 with 2 observations to Kendrick Laboratories in Madison, Wisconsin (FEI 3001238747) after an inspection that ran Mar 9 – Mar 10, 2020. The investigators were Lori B. Wikstrom and Sandra A. Boyd. Most observations concern laboratory controls and quality system; the most-cited regulation is 21 CFR 211.160 (general requirements).
At a glance
Laboratory controls and quality system account for 2 of 2 observations.
Most cited: 21 CFR 211.160(b) (1×) · 211.25(a) (1×)
What FDA observed
Preview: the opening words of each observation- 01
Laboratory controls do not include the establishment of scientifically sound and appropriate test procedures designed to…
- 02
Employees are not given training in the particular operations they perform as…
This inspection in context
Lori B. Wikstrom
5 documents · 2020–2025
Cites 211.67 (equipment cleaning and maintenance) more than any other section. Most of their documents are for sites in Wisconsin.
The firmKendrick Laboratories history
The site's inspection history, in date order.
Similar 483sOther sites cited under 211.160(b)
See how FDA wrote the same problem up elsewhere.
Questions about this 483
What did FDA find at Kendrick Laboratories?
FDA listed 2 observations on this Form 483, mostly about laboratory controls and quality system. The most-cited regulation is 21 CFR 211.160 (general requirements). The opening words of each observation are shown on this page.
Who inspected Kendrick Laboratories?
Lori B. Wikstrom and Sandra A. Boyd are named on this Form 483, for the inspection of Mar 9 – Mar 10, 2020. Each investigator has a profile showing what they cite most.
When was Kendrick Laboratories inspected by FDA?
The inspection ran Mar 9 – Mar 10, 2020, and the Form 483 is dated March 10, 2020.
How do I get the full Form 483 for Kendrick Laboratories?
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.