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21CFR211.58

§ 211.58 Maintenance.

7 citations

Regulation Text

Any building used in the manufacture, processing, packing, or holding of a drug product shall be maintained in a good state of repair.

Authority

21 U.S.C. 321,351,352,355,360b,360ddd,360ddd-1,371,374;42 U.S.C. 216,262,263a,264.

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Related Warning Letters (7)

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    Colgate-Palmolive/Tom's of Maine, Inc.

    2024-11-19

  • CGMP Deviations

    Fresenius Kabi AG

    2023-09-29

  • CGMP/Finished Pharmaceuticals/Adulterated

    Drivergent, Inc.

    2023-05-09

  • CGMP/Finished Pharmaceuticals/Adulterated/Unapproved New Drug

    Advanced Cosmetic Research Laboratories Inc.

    2022-10-25

  • CGMP/Finished Pharmaceuticals/Adulterated

    Aurolife Pharma, LLC

    2020-11-24

  • CGMP/Drug Products/Adulterated

    Auro Pharmacies, Inc., dba Central Drugs Compounding Pharmacy

    2020-06-30

  • CGMP/Finished Pharmaceuticals/Adulterated

    Acino Products, LLC

    2020-03-03

Related Guidelines (1)