Addison Biological Laboratory, Inc.
Form 483 issued September 15, 2022 · FAYETTE, Missouri
- Investigator
- Jill Tillman
- Observations
- 1
- Pages
- 2
- FEI number
- 3003624071
In short: On September 15, 2022, FDA issued a Form 483 with 1 observation to Addison Biological Laboratory, Inc. in FAYETTE, Missouri (FEI 3003624071). The investigator was Jill Tillman. Most observations concern laboratory controls; the most-cited regulation is 21 CFR 211.160 (general requirements).
At a glance
1 of 1 observations on this 483 concern laboratory controls.
Most cited: 21 CFR 211.160(b) (1×)
What FDA observed
Preview: the opening words of each observation- 01
Laboratory controls do not include the establishment of scientifically sound and appropriate specifications, standards and test…
This inspection in context
Jill Tillman
7 documents · 2020–2022
Cites 211.160 (general requirements) more than any other section. Most of their documents are for sites in Missouri.
The firmAddison Biological Laboratory, Inc. 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 Addison Biological Laboratory, Inc.?
FDA listed 1 observation on this Form 483, mostly about laboratory controls. The most-cited regulation is 21 CFR 211.160 (general requirements). The opening words of each observation are shown on this page.
Who inspected Addison Biological Laboratory, Inc.?
Jill Tillman is named on this Form 483. Each investigator has a profile showing what they cite most.
When was Addison Biological Laboratory, Inc. inspected by FDA?
This Form 483 is dated September 15, 2022.
How do I get the full Form 483 for Addison Biological Laboratory, 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.