Sanitation

Details

Sanitation is a facility level programme that keeps manufacturing and storage buildings clean and sanitary; 21 CFR 211.56 requires (a) freedom from infestation by rodents, birds, insects, and other vermin, and timely disposal of trash and organic waste, (b) written procedures assigning responsibility and describing in sufficient detail the cleaning schedules, methods, equipment, and materials, (c) procedures for the use of rodenticides, insecticides, fungicides, fumigating agents, and cleaning and sanitising agents (registered products only, used so that components, containers, and products are not contaminated), and (d) the same procedures to apply to contractors and temporary employees. If disinfection is the individual treatment that reduces microorganisms, sanitation is the wider system that includes it along with cleaning, pests, and waste, and the Canadian finding of an inadequate sanitation programme points at which of the three layers — design (identifying the contamination risk), execution, and effectiveness — is missing. Inspections cite cleaning frequencies and methods absent from the procedure or no cleaning records, pests, foreign matter, or accumulated dust observed in production areas, and hygiene procedures not applied to contracted personnel.

Related sections

Related terms

Real inspection findings

Findings from regulators' inspection documents in which this term appears.

1. Facilities (i.e.: maintenance/repairs, cleaning, sanitation) [21 CFR 1271.190(d)]; b.

   FDA · FDA Warning Letter · 2021-06-01

2. Failure to establish and follow written procedures describing in sufficient detail the methods and materials used for sanitation [21 CFR 211.56(b)].

   FDA · FDA Warning Letter · 2022-09-20

3. Your firm used a (b)(4) that is not part of a sanitation or sterilization process.

   FDA · FDA Warning Letter · 2022-02-08

Counted as of 2026-09-24 — the search you land on shows today's figures, so it may differ slightly.