FDA Intel

Applied Laboratories, Inc.

FDA inspection history in Columbus, Indiana, 2003 to 2023

1
Form 483
1
Warning letter

Every document, by year

  • Form 483
  • Warning letter

2003: one warning letter; 2023: one Form 483.

The story so far

Built from the dates and citations on the documents themselves.

  1. 2003One warning letter, at Columbus, Indiana.
  2. 2023One Form 483, at Columbus, Indiana.

Cited most

Across all Applied Laboratories observations on file

  • 21 CFR 211.84(b)
    Testing and approval or rejection of components, drug product containers, and closures
    2
  • 21 CFR 211.63
    Equipment design, size, and location
    1

The complete Applied Laboratories file.

All 2 documents as original PDFs, in one order. For supplier audits, diligence and inspection prep.

$198

The price of the documents, added to your cart together

Sites

Documents

2 on file, newest first
DateDocumentPrice
2023-10-27483 Form 483$99
2003-11-19Warning letter Warning letter$99

Investigators on these documents

Wenzheng Zhang (1)

FEI number 1831301 · most recent document Oct 27, 2023

About Applied Laboratories, Inc.

How many FDA Form 483s has Applied Laboratories, Inc. received?

FDA Intel has 1 Form 483 on file for Applied Laboratories, Inc.; the most recent is dated Oct 27, 2023.

When was Applied Laboratories, Inc. last inspected by FDA?

The most recent FDA inspection document on file for Applied Laboratories, Inc. is a Form 483 dated Oct 27, 2023, for the site in Columbus, Indiana.

What did FDA cite at Applied Laboratories, Inc.?

The regulations cited most in the observations on file for Applied Laboratories, Inc. are 21 CFR 211.84(b) (Testing and approval or rejection of components, drug product containers, and closures), 2 times; 21 CFR 211.63 (Equipment design, size, and location), 1 time.

Has Applied Laboratories, Inc. received an FDA warning letter?

Yes. FDA Intel has 1 FDA warning letter on file for Applied Laboratories, Inc.; the most recent is dated Nov 19, 2003.