Mary Pat Moyer, PhD
Chief Executive Officer and Chief Science Officer
INCELL Corporation LLC
12734 Cimarron Path
San Antonio , TX 78249
United States
lynn.miller@incell.comFEI 3004107906Issued Dec 12, 2024Center for Biologics Evaluation and Research (CBER)
Source: FDA, published letter. FDA published this warning letter; View Letter opens FDA's copy. To check it, open FDA's record for this establishment, listed under FEI 3004107906.
Violations4
Issue DateDec 12, 2024
Product TypeDrugs
StatusOpen
Letter Details
Firm
INCELL Corporation LLC
Location
Mary Pat Moyer, PhD
Chief Executive Officer and Chief Science Officer
INCELL Corporation LLC
12734 Cimarron Path
San Antonio , TX 78249
United States
lynn.miller@incell.com
FEI Number
3004107906
Country
United States
Issue Date
December 12, 2024
Issuing Office
Center for Biologics Evaluation and Research (CBER)
Product Type
Drugs
Status
Open
Summary
INCELL Corporation LLC manufactured an unapproved amniotic fluid-derived drug product without proper FDA licensure, violating sections 505(a) and 351(a)(1) of federal law. An FDA inspection between September 25-29, 2023 documented significant current good manufacturing practice (CGMP) violations under 21 CFR parts 210 and 211, rendering the product adulterated and misbranded, with the company prohibited from introducing it into interstate commerce. The violations included deficiencies in the company's manufacturing methods, facilities, and controls that failed to meet required standards for drug manufacturing, processing, packing, and holding.
INCELL Corporation LLC FDA Warning Letter, December 12, 2024
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