21 CFR 211.142
Warehousing procedures
21 CFR 211.142 is the regulation titled “Warehousing procedures” in 21 CFR Part 211, Current Good Manufacturing Practice for Finished Pharmaceuticals. Since 2021, 4 FDA warning letters have cited it.
- Letters citing it
- 4 since 2021
- Jan 1 to Oct 30, 2026
- 2 against 0 on the same dates in 2025
- Most often cited with
- 21 CFR 211.100, in 2 letters
- Closed out
- 0% of these letters have a published close-out
Letters citing it, by year issued
All are drug letters. 2026 runs to Oct 30, 2026. Pick a year to see its letters.
What FDA writes when it cites it
The finding headings that cite 21 CFR 211.142 most often, as written in the letters.
- 2 lettersYour firm failed to store drug products under appropriate conditions of temperature, humidity, and light so that the identity, strength, quality, and purity are not affected (21 CFR 211.142(b))
- 1 letterYour firm failed to establish an adequate quality unit (QU) with the responsibilities and authority to oversee the manufacturing of drug products. For example, your QU failed to ensure:
- 1 letterYour firm failed to establish and follow appropriate written procedures that are designed to prevent microbiological contamination of drug products purporting to be sterile, and that include validation of all aseptic…
The regulation
Read the text of 21 CFR 211.142 (eCFR, as of Sep 1, 2026)
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.
Text from eCFR as of Sep 1, 2026.
Cited alongside it
Regulations that appear in the same letters as 21 CFR 211.142.
- 21 CFR 211.100Written procedures; deviations2 letters cite both
- 21 CFR 211.165Testing and release for distribution2 letters cite both
- 21 CFR 211.188Batch production and control records2 letters cite both
- 21 CFR 211.192Production record review2 letters cite both
- 21 CFR 211.22Responsibilities of quality control unit2 letters cite both
- 21 CFR 200.10Contract facilities (including consulting laboratories) utilized as extramural facilities by pharmaceutical manufacturers1 letter cites both
- 21 CFR 201.115New drugs or new animal drugs1 letter cites both
- 21 CFR 201.128Meaning of “intended uses”1 letter cites both
Latest letters citing it
The 3 letters citing 21 CFR 211.142 that FDA posted most recently.
- DrugsView kdc/one Chatsworth, Inc.Your firm failed to have, for each batch of drug product, appropriate laboratory determination of satisfactory conformance to final…IssuedSep 8, 2026PostedSep 22, 2026
- DrugsView Pro Numb Tattoo Numbing Spray, LLCPro Numb Tattoo Numbing Spray, Pro Numb Tattoo Numbing Spray for Sensitive Skin, and TKTX Deep NumbsIssuedApr 14, 2026PostedApr 21, 2026
- DrugsView Atlantic Management Resources LTD dba. Claire Ellen ProductsHomeopathic drug productsIssuedJan 20, 2023PostedMar 14, 2023
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Counts include every citation in a letter, as the Letters filter does. How this database is built.