Current Inspection Trends From FDA Warning Letters


A review of warning letters posted on September 10, 2013, to the FDA website was conducted.  Four of thirteen warning letters were issued by CDRH with a subject of Quality System Regulation for Medical Devices/Adulterated.  Twenty-seven violations were identified at these four manufacturers.  A break-down of the identified violations follows:

Citation                                      Subpart (Frequency)

21 CFR 820.30 (b,d,f,g,i)           Design Controls (7)
21 CFR 820.100                        CAPA (4)
21 CFR 820.50 (a,b)                 Purchasing Controls (3)
21 CFR 820.75(a)                     Process Validation (3)
21 CFR 820.70(a,c)                  Production & Process Controls (2)
21 CFR 820.198                       Complaint Files (2)
21 CFR 820.22                         Quality Audit (1)
21 CFR 820.40                         Document Controls (1)
21 CFR 820.86                         Acceptance Status (1)
21 CFR 820.90                         Nonconforming Product (1)
21 CFR 820.120                       Device Labeling (1)
21 CFR 820.250                       Statistical Techniques (1)                1

It is interesting to note that:

Warning Letter Bio Focus addresses issues with IQ, OQ and PQ.  Specifically where acceptance criteria was not specified and the OQ as required by the firms validation procedure was not performed.

Warning Letter Vision RT addresses a number of issues concerning Design Controls.  Specifically where design changes were not implemented in accordance with firm procedures, the firm did not assure testing of production units were conducted under actual or simulated use, and lack of a statistical justification for sampling size.  Additionally, design verification was not conducted, the essential design outputs were not identified, and no planning document was available for the project.