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# Notes for Companies Using Foreign Manufacturing Sites
- URL: https://www.fdaweb.com/notes-for-companies-using-foreign-manufacturing-sites/
- Published: 2017-03-16T12:00:00.000Z
- Updated: 2026-09-14T22:12:09.000Z
- Author: David McFarland
- Tags: Drugs, #legacy-id-D5138223

Attorney **Alan Minsk** (Arnall Golden Gregory) says that so far in 2017 the CDER Office of Manufacturing Quality has released 14 Warning Letters, all involving manufacturing facilities outside the U.S. “While it is too early in the year to assess whether this reflects an increased FDA focus on foreign inspections,” he [writes](http://www.jdsupra.com/legalnews/fda-is-cold-as-ice-as-it-steps-up-88510/?ref=fdaweb.com), “companies should take note if they have manufacturing sites outside the U.S. or use contract manufacturers in other countries.” Among his recommendations: 

- companies must audit all facilities they use for compliance with FDA requirements;
- regular auditing and monitoring of foreign firms, in addition to execution of quality agreements, may help maximize regulatory compliance and minimize commercial disruption;
- a foreign site’s non-compliance can result in a Warning Letter and can lead to other consequences that have a commercial impact, such as an import alert;
- many countries have regulatory and quality standards that differ from FDA’s; and
- a good manufacturing practice problem at a foreign establishment may lead to increased scrutiny at the U.S. manufacturing facilities of the same company.