21 CFR 211.101
Charge-in of components
21 CFR 211.101 is the regulation titled “Charge-in of components” in 21 CFR Part 211, Current Good Manufacturing Practice for Finished Pharmaceuticals. Since 2021, 3 FDA warning letters have cited it.
- Letters citing it
- 3 since 2021
- Jan 1 to Oct 30, 2026
- 0 against 0 on the same dates in 2025
- Most often cited with
- 21 CFR 211.137, in 3 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 211.101 most often, as written in the letters.
- 1 letterYour firm failed to establish adequate written production and control procedures for the charge-in of components designed to assure that the drug products produced have the identity, strength, quality, and purity they…
- 1 letterYour firm failed to formulate batches of your drug product with the intent to provide not less than 100% of the labeled or established amount of active ingredient (21 CFR 211.101(a))
The regulation
Read the text of 21 CFR 211.101 (eCFR, as of Sep 1, 2026)
Written production and control procedures shall include the following, which are designed to assure that the drug products produced have the identity, strength, quality, and purity they purport or are represented to possess:
(a) The batch shall be formulated with the intent to provide not less than 100 percent of the labeled or established amount of active ingredient.
(b) Components for drug product manufacturing shall be weighed, measured, or subdivided as appropriate. If a component is removed from the original container to another, the new container shall be identified with the following information:
(1) Component name or item code;
(2) Receiving or control number;
(3) Weight or measure in new container;
(4) Batch for which component was dispensed, including its product name, strength, and lot number.
(c) Weighing, measuring, or subdividing operations for components shall be adequately supervised. Each container of component dispensed to manufacturing shall be examined by a second person to assure that:
(1) The component was released by the quality control unit;
(2) The weight or measure is correct as stated in the batch production records;
(3) The containers are properly identified. If the weighing, measuring, or subdividing operations are performed by automated equipment under § 211.68, only one person is needed to assure paragraphs (c)(1), (c)(2), and (c)(3) of this section.
(d) Each component shall either be added to the batch by one person and verified by a second person or, if the components are added by automated equipment under § 211.68, only verified by one person.
[43 FR 45077, Sept. 29, 1978, as amended at 73 FR 51932, Sept. 8, 2008]
Text from eCFR as of Sep 1, 2026.
Cited alongside it
Regulations that appear in the same letters as 21 CFR 211.101.
- 21 CFR 211.137Expiration dating3 letters cite both
- 21 CFR 211.165Testing and release for distribution3 letters cite both
- 21 CFR 211.84Testing and approval or rejection of components, drug product containers, and closures3 letters cite both
- 21 CFR 201.128Meaning of “intended uses”2 letters cite both
- 21 CFR 211.188Batch production and control records2 letters cite both
- 21 CFR 211.22Responsibilities of quality control unit2 letters cite both
- 21 CFR 201.10Drugs; statement of ingredients1 letter cites both
- 21 CFR 201.61Statement of identity1 letter cites both
Latest letters citing it
The 3 letters citing 21 CFR 211.101 that FDA posted most recently.
- DrugsView Aromas Para El Alma S.A.Hand sanitizer and antibacterial spray drug productsIssuedSep 10, 2024PostedSep 17, 2024
- DrugsView Betone S.A. de C.V.OTC (b)(4) wipe drug productsIssuedMar 21, 2024PostedApr 2, 2024
- DrugsView PureChemPros LLCOTC hand sanitizers and hydrogen peroxide productsIssuedSep 1, 2023PostedSep 19, 2023
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Counts include every citation in a letter, as the Letters filter does. How this database is built.