§ 211.142 Warehousing procedures

Written procedures describing the warehousing of drug products shall be established and followed. They shall include:

(a) Quarantine of drug products before release by the quality control unit.

(b) Storage of drug products under appropriate conditions of temperature, humidity, and light so that the identity, strength, quality, and purity of the drug products are not affected.

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What FDA inspectors cite under § 211.142

Form FDA 483 observations citing this section, fiscal years 2009–2026 (Drugs).

• Storage under appropriate conditions 291
• Written warehousing procedures established/followed 193
• Quarantine - actual practice 44
• Quarantine - written procedures 27

Warning letters citing § 211.142

5 FDA warning letters since 2017 cite this section :

• kdc/one Chatsworth, Inc. 8 Sept 2026
• Pro Numb Tattoo Numbing Spray, LLC 14 Apr 2026
• Atlantic Management Resources LTD dba. Claire Ellen Products 20 Jan 2023
• Infusion Options, Inc. 26 Aug 2021
• Barox Co., Ltd. 28 Nov 2018

FDA guidance that cites § 211.142

• Current Good Manufacturing Practice Requirements for Combination Products: Guidance for Industry and FDA Staff 11 Jan 2017
• Current Good Manufacturing Practice for Phase 1 Investigational Drugs: Guidance for Industry 14 Jul 2008
• Quality Systems Approach to Pharmaceutical Current Good Manufacturing Practice Regulations 2 Oct 2006

Amendment history

Federal Register documents that created or amended this section.

• 43 FR 45077 29 Sept 1978