The QMN Weekly Bulletin
Pharmaceuticals / Quality / Regulatory Affairs / Inspections and Audits

Poor Investigations, Documentation Lead Form 483 Observations in 2013

Jan. 24, 2014

Poor investigations into batch failures and lax procedural documentation were the top reasons drugmakers received FDA Form 483s in 2013.

The top citations from 2013, which the FDA released Jan. 15, largely mirror the 2012 results. The good news for industry: in 2013, the number of form 483s dropped. The agency issued 690 483s from roughly 3,100 establishment inspections. In 2012, 787 were issued.

The top 10 observations in 2013, as noted in the FDA’s annual inspections statistics report, are:

  1. Responsibilities and procedures for the quality control unit aren’t in writing or fully followed (cited in 155 forms);

  2. Failure to review and investigate the failure of a batch or any of its components (131);

  3. No written procedures for production and process controls (106);

  4. Laboratory controls are not scientifically sound or appropriate (99);

  5. Written procedures aren’t established for maintenance of plant equipment (77);

  6. Procedures to prevent microbiological contamination of sterile products are not established, written or followed (76);

  7. Equipment and utensils are not cleaned, maintained or sanitized properly (71);

  8. Testing of drug products  prior to release doesn’t include appropriate laboratory determination of conformance to specifications for active ingredient (66);

  9. Control procedures aren’t established to monitor or validate manufacturing processes (65); and

  10. No written testing program established to assess stability (62).

There were some key differences in the 483 findings in 2013, however. In 2012, there were far fewer deficiencies for positron emission tomography (PET) drugs. Those citations doubled to more than two dozen in 2013 for various reasons, including failure to document procedures. That increase reflects the FDA’s commitment in 2012 to increase inspections of PET drug plants to improve oversight.

Also in 2012, lacking procedures to prevent microbiological contamination of sterile drug products was the 15th most cited observation. FDA officials attribute the 2013 rise to sixth place for microbiological contamination to the agency’s sweep of surprise inspections of compounding pharmacies.

Are you a recent recipient of a Form 483? Are you looking to ensure that you never receive another one? Secrets of FDA Drug and Biologics Inspection Preparation will help you prepare for the next, and every subsequent, FDA inspection, so order your copy.