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21 CFR 111.103 citations

Written procedures - quality control operations, reprocessin

FDA investigators cited 21 CFR 111.103 909 times at 726 facilities in the inspection citations FDA publishes, most recently in an inspection that ended Sep 30, 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 yearCitations
202666
202558
202459
202353
202262
202137
202037
201974
201863
201778

Recent citations

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

Inspection endedFacilityCountryObservation
Sep 30, 2026Wand Packaging Inc.United StatesYou did not establish written procedures for quality control operations.
Sep 18, 2026MuscleMart Inc.United StatesYou did not establish written procedures for quality control operations.
Sep 18, 2026NCAQCO, LLCUnited StatesYou did not establish written procedures for quality control operations.
Sep 4, 2026Hack Technologies LLCUnited StatesYou did not follow written procedures for quality control operations.
Sep 4, 2026Immune Tree, Inc.United StatesYou did not follow written procedures for quality control operations.
Aug 28, 2026Ancient Formulas, Inc.United StatesYou did not establish written procedures for quality control operations.
Aug 28, 2026Sundance Botanicals, LLCUnited StatesYou did not establish written procedures for quality control operations.
Aug 27, 2026Karuna Kava And Tea LLCUnited StatesYou did not establish written procedures for quality control operations.
Aug 27, 2026RAPHA Health Network International, Inc.United StatesYou did not establish written procedures for quality control operations.
Aug 13, 2026USA-AGP Pharma LLCUnited StatesYou did not establish written procedures for quality control operations.
Aug 12, 2026Ele Chocolates, LLCUnited StatesYou did not establish written procedures for quality control operations.
Aug 11, 2026Beauty & Spa ConceptsUnited StatesYou did not establish written procedures for quality control operations.
Aug 4, 2026KangyacareUnited StatesYou did not establish written procedures for quality control operations.
Jul 31, 2026Marlyn Nutraceuticals IncUnited StatesYou did not follow written procedures for quality control operations.
Jul 31, 2026Nutrixen Healthy LLCUnited StatesYou did not establish written procedures for quality control operations.
Jul 23, 2026NHC Group IncUnited StatesYou did not establish written procedures for quality control operations.
Jul 21, 2026Country Doctor HerbalsUnited StatesYou did not follow written procedures for quality control operations.
Jul 21, 2026Sentry Manufacturing, Inc.United StatesYou did not establish written procedures for quality control operations.
Jul 16, 2026Synchpack Inc.United StatesYou did not follow written procedures for quality control operations.
Jun 18, 2026Sprinkk LLCUnited StatesYou did not establish written procedures for quality control operations.
Jun 16, 2026Nature's Rare LLCUnited StatesYou did not establish written procedures for quality control operations.
Jun 11, 2026Professional Business Associates IncUnited StatesYou did not establish written procedures for quality control operations.
Jun 11, 2026Summerland Sales LLCUnited StatesYou did not establish written procedures for quality control operations.
Jun 11, 2026Trinity Natural Health & Pain Management,Inc.United StatesYou did not establish written procedures for quality control operations.
Jun 5, 2026Healthy Land Inc.United StatesYou did not establish written procedures for quality control operations.

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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.

Sources: openFDA, FDA Data Dashboard, FDA.gov. Report a data issue: hello@regdatalab.com.