Common Design Control Citations in 483s

FDA 483s Issued to Medical Device Firms

Common Design Control Violations

FDA Inspection Puzzle

In 2013, FDA has issued inspectional observations (483s) to 1099 device firms according to the FDA systems data (FDA data).

In our analysis of other years, common design control citations in 483s and FDA warning letters reveal similar patterns of citations although some frequency of citations for a specific sub-section under 21 CFR section 820.30 may vary.

*:Inspections ending between 10/1/2012 12:00:00 AM and 9/30/2013 12:00:00 AM. The FDA data does not represent the complete set of 483’s issued during the fiscal year as some 483’s were manually prepared and not available in this format. The sum of 483’s for all Product Areas will be greater than the actual total 483’s issued during the fiscal year since a 483 may include citations related to multiple product areas, and counted more than once, under each relevant product center.

Download the List in PDF

[download id=”19843″]

The following represents those citations of medical device design control in the order of 483 citation frequency.

  Regulations Citations # Short Description Long Description
1 21 CFR 820.30(i) 93 Design changes – Lack of or Inadequate Procedures Procedures for design change have not been [adequately] established.  Specifically,***
2 21 CFR 820.30(g) 61 Design validation- Lack of or inadequate procedures Procedures for design validation have not been [adequately] established.  Specifically,***
3 21 CFR 820.30(a) 55 Design control – no procedures Procedures for design control have not been established.  Specifically,***
4 21 CFR 820.30(g) 52 Design Validation – Risk analysis not performed/inadequate Risk analysis [was not performed] [is inadequate] [is incomplete].  Specifically, ***
5 21 CFR 820.30(f) 37 Design verification – Lack of or inadequate procedures Procedures for design verification have not been [adequately] established.  Specifically,***
6 21 CFR 820.30(j) 37 Design history file The design history file [was not established] [does not demonstrate that the design was developed following the approved design plan] [does not demonstrate that the design was developed following the requirements of 21 CFR 820].
7 21 CFR 820.30(e) 28 Design review – Lack of or inadequate procedures Procedures for design review have not been [adequately] established.  Specifically,***
8 21 CFR 820.30(f) 24 Design verification – output does not meet input requirement Design verification does not confirm that design output meets design input requirements.  Specifically, ***
9 21 CFR 820.30(b) 20 Design plans – Lack of or  inadequate Design plans that describe or reference the design and development activities and define responsibility for implementation have not been [adequately] established.  Specifically, ***
10 21 CFR 820.30(b) 20 Design plans – Lack of or  inadequate Design plans that describe or reference the design and development activities and define responsibility for implementation have not been [adequately] established.  Specifically, ***
11 21 CFR 820.30(c) 20 Design input – documentation Design input requirements were not [adequately] documented.   Specifically, ***
12 21 CFR 820.30(h) 19 Design transfer – Lack of or inadequate procedures Procedures for design transfer have not been [adequately] established.  Specifically,***
13 21 CFR 820.30(g) 13 Design validation – documentation The results of design validation, including [identification of the design] [method(s)] [the date] [the individual(s) performing validation], were not [adequately] documented in the design history file.  Specifically, ***
14 21 CFR 820.30(c) 13 Design input – Lack of or inadequate procedures Procedures for design input have not been [adequately] established.  Specifically,***
15 21 CFR 820.30(f) 12 Design verification – documentation The design verification results, including [identification of the design] [method(s)] [the date] [the individual(s) performing the verification], were not [adequately] documented in the design history file.  Specifically, ***
16 21 CFR 820.30(g) 10 Design validation – production units The design was not validated [under defined operating conditions] [using initial production units, lots or batches or their equivalents].  Specifically, ***
17 21 CFR 820.30(g) 10 Design validation – user needs and intended uses Design validation did not ensure the device conforms to defined user needs and intended uses.  Specifically, ***
18 21 CFR 820.30(d) 10 Design output – Lack of or inadequate procedures Procedures for design output have not been [adequately] established.  Specifically,***
19 21 CFR 820.30(e) 9 Design review – documentation The design review results, including [identification of the design] [the date] [the individual(s) performing the review], were not documented in the design history file.  Specifically, ***
20 21 CFR 820.30(g) 8 Design validation – software validation not performed Validation of device software [was not performed] [is inadequate] [is incomplete].  Specifically, ***
21 21 CFR 820.30(g) 8 Design validation – Risk analysis Results of the design risk analysis were not [adequately] documented.  Specifically, ***
22 21 CFR 820.30(h) 8 Incorrect translation to production specifications The device design was not correctly translated into production specifications.  Specifically, ***
23 21 CFR 820.30(g) 7 Design validation acceptance criteria Acceptance criteria were not established prior to the performance of validation activities.  Specifically, ***
24 21 CFR 820.30(g) 6 Design validation – software validation documentation Results of the validation of the device software were not [adequately] documented.  Specifically, ***
25 21 CFR 820.30(d) 5 Design output – documentation Design output was not [adequately] documented before release.  Specifically, ***
26 21 CFR 820.30(b) 4 Design plans- updated Design plans were not [reviewed] [updated] [approved] as design and development evolves.  Specifically, ***
27 21 CFR 820.30(e) 3 Design review procedures – personnel Procedures were not [established] [defined] [documented] [complete] [implemented] for ensuring that participants at each design review include [representatives of all functions concerned with the design stage being reviewed] [an individual who does not have direct responsibility for the design stage being reviewed] [any specialists needed].  Specifically, ***
28 21 CFR 820.30(d) 2 Design output – review and approval Design output was not [reviewed] [approved] before release.  Specifically, ***
29 21 CFR 820.30(g) 2 Design validation – simulated testing The design was not validated under actual or simulated use conditions.  Specifically, ***
30 21 CFR 820.30(c) 2 Design input – review and approval Design input requirements were not [reviewed] [approved] by designated individual(s).  Specifically, ***

Note: Total: 598 times of citations of design control violations among 483s issued to 1099 device firms in 2013.

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Last Updated: 2015-08-20

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