Applied Laboratories, Inc.
Form 483 issued October 27, 2023 · Columbus, Indiana
- Inspection
- Oct 24 – Oct 27, 2023
- Investigator
- Wenzheng Zhang
- Observations
- 3
- Pages
- 3
- FEI number
- 1831301
In short: On October 27, 2023, FDA issued a Form 483 with 3 observations to Applied Laboratories, Inc. in Columbus, Indiana (FEI 1831301) after an inspection that ran Oct 24 – Oct 27, 2023. The investigator was Wenzheng Zhang. Most observations concern materials and facilities & equipment; the most-cited regulation is 21 CFR 211.84 (testing and approval or rejection of components, drug product containers, and closures).
At a glance
2 of 3 observations on this 483 concern materials.
What FDA observed
Preview: the opening words of each observationDashed: section inferred by FDA Intel and checked against the regulation text
- 01
The identity of each component of a drug product is not verified by conducting at least…
- 02
The number of containers to be sampled is not…
- 03
Equipment used in the manufacture, processing, packing or holding of drug products is not of appropriate…
This inspection in context
Wenzheng Zhang
8 documents · 2019–2023
Cites 211.160 (general requirements) more than any other section. Most of their documents are for sites in California.
The firmApplied Laboratories, Inc. history
All 2 documents on file for this site, in date order, with what was cited at each inspection.
Similar 483sOther sites cited under 211.84(d)(1)
See how FDA wrote the same problem up elsewhere.
Questions about this 483
What did FDA find at Applied Laboratories, Inc.?
FDA listed 3 observations on this Form 483, mostly about materials and facilities & equipment. The most-cited regulation is 21 CFR 211.84 (testing and approval or rejection of components, drug product containers, and closures). The opening words of each observation are shown on this page.
Who inspected Applied Laboratories, Inc.?
Wenzheng Zhang is named on this Form 483, for the inspection of Oct 24 – Oct 27, 2023. Each investigator has a profile showing what they cite most.
When was Applied Laboratories, Inc. inspected by FDA?
The inspection ran Oct 24 – Oct 27, 2023, and the Form 483 is dated October 27, 2023.
How do I get the full Form 483 for Applied 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.