FDA 483 Citations

Holding, distribution and reserve sample citations appeared more than 60 times on FDA 483s at dietary supplement firms in fiscal year 2025. This guide explains both and how to respond.

Missing procedures for returned dietary supplements drew 54 FDA 483 citations in fiscal year 2025. This guide explains Subpart N and how to handle returns, salvage and investigations.

Missing written quality control procedures drew 54 FDA 483 citations at dietary supplement firms in fiscal year 2025. This guide explains the quality control unit's duties under Part 111.

Batch production record citations appeared 130 times on FDA 483s at dietary supplement firms in fiscal year 2025. This guide lists what each record needs and how to respond.

Master manufacturing record citations appeared 168 times on FDA 483s at dietary supplement firms in fiscal year 2025. This guide lists what an MMR must contain and how to respond.

Relying on supplier certificates of analysis without qualifying the supplier drew more than 60 FDA 483 citations in fiscal year 2025. This guide explains how COA qualification works.

Failing to test the identity of each dietary ingredient before use drew 66 FDA 483 citations in fiscal year 2025. This guide explains the rule, valid methods and how to respond.

Missing component specifications drew 177 FDA 483 citations at dietary supplement firms in fiscal year 2025. This guide explains what each component needs and how to respond.

Missing finished product specifications was the most cited dietary supplement observation in fiscal year 2025, with 188 FDA 483 citations. This guide explains it and the finished batch testing that goes with it.

Unreported device corrections and removals drew 12 FDA 483 citations in fiscal year 2025. This guide explains when Part 806 requires a report within 10 working days and how to respond.

Statistical technique and sampling plan citations appeared more than 30 times on FDA device 483s in fiscal year 2025. This guide explains how to justify sampling and respond.

Servicing procedure citations appeared 13 times on FDA device 483s in fiscal year 2025. This guide explains servicing requirements, the link to complaints and MDRs, and how to respond.

Software used in production or the quality system went unvalidated in 17 FDA 483 citations in fiscal year 2025. This guide explains the citation and a risk-based way to respond.

Calibration and test equipment citations under 21 CFR 820.72 appeared 30 times on FDA 483s in fiscal year 2025. This guide explains the citation, out-of-tolerance impact assessment and how to respond.

Equipment maintenance schedule citations appeared 19 times on FDA device 483s in fiscal year 2025. This guide explains the citation and how to build a preventive maintenance program FDA will accept.

Environmental and contamination control citations appeared 55 times on FDA device 483s in fiscal year 2025. This guide explains what investigators found and how to fix cleanroom and contamination controls.

Production and process control citations under 21 CFR 820.70(a) appeared more than 40 times on FDA 483s in fiscal year 2025. This guide explains them and how to respond.

Acceptance activity citations appeared more than 100 times on FDA device 483s in fiscal year 2025. This guide covers receiving, in-process and final acceptance and how to answer each citation.

The device master record was cited 30 times on FDA 483s in fiscal year 2025. Under QMSR it becomes the medical device file. This guide explains the citation and how to fix it.

Device history record citations appeared nearly 90 times on FDA 483s in fiscal year 2025. This guide explains what investigators found in batch records and how to fix them.