FDA warning letter threatens Celltrion's valuable Inflectra franchise
Pfizer’s (NYSE: PFE) manufacturing partner in South Korea Celltrion (Kosdaq: 068270) has received a warning letter from the US Food and Drug Administration after an inspection of its Incheon-based facility uncovered “issues related to certain manufacturing processes.”
The FDA says its inspection in the first part of 2017 revealed “significant violations of current good manufacturing practice (CGMP).”
The firm says it’s “making progress addressing these concerns” and that it will “provide a full response to the FDA within the next 15 days.”
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