News / Presse
FDA Inspection Successfully Passed
In 2019 HAPILA GmbH had the first in-house GMP inspection by the American Health Authority FDA lasting several days. During this inspection our company was checked for compliance with the USFDA requirements ("facility for compliance with USFDA requirements").
The inspection was successful: FDA has concluded that this inspection is "closed" under 21 CFR 20.64(d)(3).
In addition to the present EU GMP certifications for 5 active pharmaceutical ingredients, also the US American side has attested HAPILA GmbH a high GMP level for the manufacture and the auditing of active pharmaceutical ingredients.