Supplier Questionnaires and their Way into a FDA 483

Questionnaires are a useful tool for obtaining information from a supplier and making initial considerations regarding audit planning. For a new supplier, questions about the nature of the quality management system provide an initial indication. The size of the company can have an influence on the duration of a possible audit and the number of auditors.

However, questionnaires are not suitable as the sole element for qualifying a supplier. And Audits are mandatory for API suppliers. A pharmaceutical manufacturer in India has now completely dispensed with auditing its API suppliers and simply sent them questionnaires. In an inspection carried out by the US Food and Drug Administration (FDA) in October, this promptly led to one observation (one of many, by the way): "The quality unit has not ensured API suppliers are appropriate for use." (...) "No onsite audit has been conducted for any supplier of APIs...". Worse still, some of the suppliers did not return the questionnaires and were used anyway. One of the suppliers was at least honest and stated that he did not carry out ICH-compliant stability tests, did not qualify the water system and did not test it regularly. He was nevertheless qualified.

A total of 14 observations were noted in this 20-page report, with a number of deficiencies, e.g:

  • No adequate procedure to prevent microbial contamination during manufacturing and cleaning processes
  • Inadequate laboratory controls, records and reports. The same for manufacturing documentation
  • Inadequate smoke studies and media fills
  • Buildings in poor condition
  • No identity testing for incoming APIs
  • Insufficient stability testing


Incidentally, the plant was then issued with an "Import Alert" on 23 October 2023, three days after the 483 was issued on 20 October 2023.

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