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news.Haupt Pharma has successfully passed inspection by the FDA at its Italian site without any FDA-483 observation being issued.
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The company said that the inspection covered all areas of the organisation and systems involved in the production of sterile penicillin products. After the seven-day audit, the site is approved to produce two sterile penicillin antibiotics for the US market.
The first pre-approval inspection at the Latina site was triggered by the submission of two pre-approval supplements for sterile penicillin products from one of Haupt Pharma’s customers.
Haupt Pharma is able to deliver from five FDA-inspected sites in Italy and Germany high-quality products for the demanding and regulated US market.
Hans-Christian Semmler, CEO, said: “We have reached an important milestone by successfully passing the FDA inspection in Latina, which confirms the high standards of good manufacturing practice at our company.”
Haupt Pharma Latina, the Italian site has extensive experience in contract manufacturing, packaging and the quality control of conventional dosage forms, as well as specific expertise in beta-lactam and veterinary products both sterile and non-sterile.