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21 CFR 211.22(a) citations

Lack of quality control unit

FDA investigators cited 21 CFR 211.22(a) 835 times at 746 facilities in the inspection citations FDA publishes, most recently in an inspection that ended Aug 12, 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
202628
202551
202451
202335
202241
202117
202026
201956
201861
201766

Recent citations

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

Inspection endedFacilityCountryObservation
Aug 12, 2026Mountainside Medical Equipment, Inc.United StatesThere is no quality control unit.
Jul 17, 2026I. Shay Cosmetics IncUnited StatesThe quality control unit lacks the responsibility and authority to approve and reject all components, drug product containers, closures, in process materials, packaging material, labeling and drug products.
Jun 12, 2026The Flower Remedy LLCUnited StatesThe quality control unit lacks the responsibility and authority to approve and reject all components, drug product containers, closures, in process materials, packaging material, labeling and drug products.
Jun 5, 2026My CHS Rx, Inc.United StatesThere is no quality control unit.
Jun 4, 2026Nexus Pharmaceuticals, LLCUnited StatesThe quality control unit lacks authority to fully investigate errors that have occurred.
May 20, 2026Talbot's Pharmaceuticals Family Products, LLCUnited StatesThe quality control unit lacks responsibility for approving or rejecting drug products manufactured, processed and packed under contract by another company.
May 1, 2026GVS TM, IncUnited StatesThe quality control unit lacks the responsibility and authority to approve and reject all components, drug product containers, closures, in process materials, packaging material, labeling and drug products.
Mar 19, 2026PReye LLCUnited StatesThere is no quality control unit.
Mar 10, 2026Cosmetic Lab, Inc.United StatesThe quality control unit lacks the responsibility and authority to approve and reject all components.
Mar 5, 2026SURETEC INNOVATIONS LLCUnited StatesThere is no quality control unit.
Feb 19, 2026LICO Industries, LLCUnited StatesThere is no quality control unit.
Feb 5, 2026Fenwal International, Inc.United StatesThe quality control unit lacks authority to fully investigate errors that have occurred.
Feb 5, 2026NexCell Scientific IncUnited StatesThere is no quality control unit.
Jan 30, 2026Safrel Pharmaceuticals LLCUnited StatesThere is no quality control unit.
Jan 16, 2026Dabur India LimitedIndiaThe quality control unit lacks authority to review production records to assure that no errors have occurred and fully investigate errors that have occurred.
Jan 12, 2026Skytronics Led, IncUnited StatesThere is no quality control unit.
Dec 19, 2025KaryoLogic IncUnited StatesThere is no quality control unit.
Dec 16, 2025Bello Bio LLCUnited StatesThere is no quality control unit.
Dec 16, 2025Regen Suppliers LLCUnited StatesThere is no quality control unit.
Dec 4, 2025St Mary's Medical Park PharmacyUnited StatesThere is no quality control unit.
Nov 28, 2025Analytical SolutionsIndiaThe quality control unit lacks authority to fully investigate errors that have occurred.
Nov 21, 2025Eagle Analytical Services, Inc.United StatesThe quality control unit lacks authority to review production records to assure that no errors have occurred and fully investigate errors that have occurred.
Nov 21, 2025Sato Pharmaceutical Co., Ltd.JapanThe quality control unit lacks the responsibility and authority to approve and reject all drug products.
Nov 20, 2025WES Pharma Inc.United StatesThe quality control unit lacks authority to fully investigate errors that have occurred.
Nov 18, 2025Actavis Laboratories FL, Inc.United StatesThe quality control unit lacks authority to review production records to assure that no errors have occurred and fully investigate errors that have occurred.

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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.