> ## 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.

# 8 Observations in Brookfield Supply FDA-483
- URL: https://www.fdaweb.com/8-observations-in-brookfield-supply-fda-483/
- Published: 2019-03-07T12:00:00.000Z
- Updated: 2026-09-15T01:10:40.000Z
- Author: David McFarland
- Tags: Drugs, #legacy-id-D5143556

FDA has released the FDA-483 with eight observations from a 12/10-12/21/18 inspection at Brookfield Medical/Surgical Supply, a Brookfield, CT, outsourcing facility. The inspection observations were: 

- · failing to have written procedures for production and process controls designed to assure that the drug products have the identity, strength, quality, and purity they purport or are represented to possess;
- aseptic processing areas are deficient regarding the system for monitoring environmental conditions;
- aseptic processing areas are deficient regarding the system for cleaning and disinfecting the room and equipment to produce aseptic conditions;
- failing to subject to microbiological tests before use each lot of a component that is liable to microbiological contamination that is objectionable in view of its intended use;
- failing to follow procedures designed to prevent microbiological contamination of drug products purporting to be sterile;
- failing to maintain equipment and utensils at appropriate intervals to prevent malfunctions that would alter the safety, strength, quality, or purity of the drug product;
- failing to collect and retain samples for any of the finished drug products … that have been manufactured since the firm began operations in 2015; and
- compounding drugs that are essentially a copy of one or more approved drugs within the meaning of sections 503B(a)(5) and 503B(d)(2).