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21 CFR 211.84(d)(2) citations

Testing Each Component for Conformity with Specs

FDA investigators cited 21 CFR 211.84(d)(2) 890 times at 691 facilities in the inspection citations FDA publishes, most recently in an inspection that ended Aug 11, 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
202634
202583
202465
202342
202240
202121
202019
201955
201846
201753

Recent citations

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

Inspection endedFacilityCountryObservation
Aug 11, 2026Advanced Accelerator Applications USA, Inc.United StatesComponent testing is deficient in that each component is not tested for conformity with all appropriate written specifications for purity, strength, and quality.
Jul 28, 2026Graviti Pharmaceuticals Private LimitedIndiaComponent testing is deficient in that each component is not tested for conformity with all appropriate written specifications for purity, strength, and quality.
Jul 23, 2026Fuller Industries IncUnited StatesComponent testing is deficient in that each component is not tested for conformity with all appropriate written specifications for purity, strength, and quality.
Jul 22, 2026Neilmed Pharmaceuticals IncUnited StatesEstablishment of the reliability of the component supplier's report of analyses is deficient in that the test results are not appropriately validated at appropriate intervals.
Jul 2, 2026Biolink Life Sciences Carolinas Inc.United StatesSpecific identification tests are not conducted on components that have been accepted based on the supplier's report of analysis.
Jun 26, 2026Advanced Cosmetic Research Laboratories, Inc.United StatesComponent testing is deficient in that each component is not tested for conformity with all appropriate written specifications for purity, strength, and quality.
Jun 26, 2026Advanced Cosmetic Research Laboratories, Inc.United StatesEstablishment of the reliability of the component supplier's report of analyses is deficient in that the test results are not appropriately validated at appropriate intervals.
Jun 26, 2026Natural Essentials IncorporatedUnited StatesComponent testing is deficient in that each component is not tested for conformity with all appropriate written specifications for purity, strength, and quality.
Jun 26, 2026S.S.S. Company (International)United StatesComponent testing is deficient in that each component is not tested for conformity with all appropriate written specifications for purity, strength, and quality.
May 29, 2026Cosmoceutical Research Center, Inc.United StatesReports of analysis from component suppliers are accepted in lieu of testing each component for conformity with all appropriate written specifications, without performing at least one specific identity test on each…
May 20, 2026Belmar Labs, LLCUnited StatesSpecific identification tests are not conducted on components that have been accepted based on the supplier's report of analysis.
May 7, 2026Topical Pharmaceuticals, Inc.United StatesComponent testing is deficient in that each component is not tested for conformity with all appropriate written specifications for purity, strength, and quality.
May 1, 2026SnugZ USA, Inc.United StatesComponent testing is deficient in that each component is not tested for conformity with all appropriate written specifications for purity, strength, and quality.
Apr 29, 2026Samson Pharmaceuticals, IncUnited StatesEstablishment of the reliability of the component supplier's report of analyses is deficient in that the test results are not appropriately validated at appropriate intervals.
Apr 17, 2026Optimal Solution Labs LLCUnited StatesEstablishment of the reliability of the component supplier's report of analyses is deficient in that the test results are not appropriately validated at appropriate intervals.
Apr 9, 2026Lantheus Medical Imaging, Inc.United StatesComponent testing is deficient in that each component is not tested for conformity with all appropriate written specifications for purity, strength, and quality.
Mar 20, 2026Eosera, Inc.United StatesEach component is not tested for conformity with all appropriate written specifications for purity, strength, and quality.
Feb 26, 2026CoreRX Inc.United StatesComponent testing is deficient in that each component is not tested for conformity with all appropriate written specifications for purity, strength, and quality.
Feb 26, 2026Smith & Nephew Wound ManagementUnited StatesEach component is not tested for conformity with all appropriate written specifications for purity, strength, and quality.
Feb 20, 2026Acme Generics Private LimitedIndiaEach component is not tested for conformity with all appropriate written specifications for purity, strength, and quality.
Feb 12, 2026Enemeez LLCUnited StatesComponent testing is deficient in that each component is not tested for conformity with all appropriate written specifications for purity, strength, and quality.
Feb 6, 2026Tarmac Products, Inc.United StatesSpecific identification tests are not conducted on components that have been accepted based on the supplier's report of analysis.
Jan 26, 2026Spa De Soleil, Inc.United StatesSpecific identification tests are not conducted on components that have been accepted based on the supplier's report of analysis.
Jan 15, 2026Goodier Cosmetics LLCUnited StatesComponent testing is deficient in that each component is not tested for conformity with all appropriate written specifications for purity, strength, and quality.
Dec 22, 2025Blaine Labs IncUnited StatesEstablishment of the reliability of the component supplier's report of analyses is deficient in that the test results are not appropriately validated at appropriate intervals.

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