> ## Content Index
> Fetch the complete content index at: https://www.fdaweb.com/llms.txt
> Use this file to discover other available public pages before exploring further.

# 5 Observations on BPI Labs FDA-483
- URL: https://www.fdaweb.com/5-observations-on-bpi-labs-fda-483/
- Published: 2022-06-09T12:00:00.000Z
- Updated: 2026-09-14T17:48:06.000Z
- Author: David McFarland
- Tags: Drugs, #legacy-id-D5152022

FDA has released the FDA-483 issued following a 4/19-4/30/21 inspection at BPI Labs, a Largo, FL, sterile drug manufacturer and outsourcing facility. The five inspection observations were: 

- equipment used in the manufacture, processing, packing, or holding of drug products is not of appropriate design to facilitate operations for its intended use;
- potential suppliers were not evaluated and selected based on their ability to meet specified requirements;
- risk analysis is inadequate;
- failing to adequately establish procedures for design transfer; and
- failing to clearly define the type and extent of control to be exercised over the product and suppliers.