21 CFR 111.453 citations

Written procedures - holding

FDA investigators cited 21 CFR 111.453 565 times at 510 facilities in the inspection citations FDA publishes, most recently in an inspection that ended Oct 8, 2026. A citation is an observation listed on Form FDA 483 at the end of an inspection; it is not a final agency decision.

Citations by fiscal year

FDA fiscal year	Citations
2027	2
2026	50
2025	45
2024	36
2023	38
2022	32
2021	21
2020	23
2019	44
2018	47

Recent citations

The latest inspections that cited this section. Facility names link to each facility's FDA record.

Inspection ended	Facility	Country	Observation
Oct 8, 2026	Health Value Inc.	United States	You did not follow written procedures for holding and distributing operations.
Oct 7, 2026	Healthtex Distributors, LLC	United States	You did not follow written procedures for holding and distributing operations.
Sep 18, 2026	MuscleMart Inc.	United States	You did not establish written procedures for holding and distributing operations.
Sep 14, 2026	Better Than Greens LLC	United States	You did not establish written procedures for holding and distributing operations.
Aug 28, 2026	Yep Strength	United States	You did not establish written procedures for holding and distributing operations.
Aug 27, 2026	Karuna Kava And Tea LLC	United States	You did not establish written procedures for holding and distributing operations.
Aug 24, 2026	Suyat Enterprises, LLC	United States	You did not establish written procedures for holding and distributing operations.
Aug 24, 2026	VitaNorth USA, LLC	United States	You did not follow written procedures for holding and distributing operations.
Aug 12, 2026	MultiSales Incorporated	United States	You did not establish written procedures for holding and distributing operations.
Jul 23, 2026	Immudyne Nutritional LLC	United States	You did not establish written procedures for holding and distributing operations.
Jul 23, 2026	NHC Group Inc	United States	You did not establish written procedures for holding and distributing operations.
Jul 8, 2026	Carefast Products Inc	United States	You did not establish written procedures for holding and distributing operations.
Jul 8, 2026	Nu-Scripts, Inc	United States	You did not establish written procedures for holding and distributing operations.
Jun 11, 2026	Professional Business Associates Inc	United States	You did not establish written procedures for holding and distributing operations.
Jun 5, 2026	Healthy Land Inc.	United States	You did not establish written procedures for holding and distributing operations.
Jun 4, 2026	LNS US LLC	United States	You did not establish written procedures for holding and distributing operations.
Jun 3, 2026	G&G Supplements	United States	You did not establish written procedures for holding and distributing operations.
May 22, 2026	Brand Elevation Partners, LLC	United States	You did not establish written procedures for holding and distributing operations.
May 15, 2026	Hoa Da Canh Thien, Inc.	United States	You did not establish written procedures for holding and distributing operations.
May 14, 2026	SCP Inc	United States	You did not establish written procedures for holding and distributing operations.
May 11, 2026	Lifeaid Beverage Company, LLC	United States	You did not establish written procedures for holding and distributing operations.
May 7, 2026	Mytosynth Nutraceuticals, LLC	United States	You did not establish written procedures for holding and distributing operations.
Apr 29, 2026	Aloe Queen, Inc.	United States	You did not follow written procedures for holding and distributing operations.
Apr 9, 2026	America Great Health	United States	You did not establish written procedures for holding and distributing operations.
Apr 9, 2026	Symbia Fulfillment Services Of NV - Reno 1	United States	You did not establish written procedures for holding and distributing operations.

Search more

Search every Form 483 citation by company with the FDA 483 search, see all frequently cited CFR sections, or check one supplier with the free FDA compliance check.