FDA WARNING_LETTER - CellEra LLC - July 08, 2021

On October 20, 2021, the FDA issued a Warning Letter to CellEra LLC following an inspection from June 16 to July 8, 2021, at their Monroe, OH facility. The inspection revealed that CellEra LLC, a specification developer and own-label distributor of sterile wound dressings with drug, had adulterated devices under 21 U.S.C. § 351(h) due to non-conformity with Quality System (QS) regulation (21 CFR Part 820).

The letter detailed numerous repeated violations from a May 30, 2019, FDA 483 and a January 14, 2020, Regulatory Meeting. Key violations include: 1. **Failure to establish and maintain CAPA procedures (21 CFR § 820.100):** Undocumented corrective actions, including changes to Instructions for Use (IFUs) for Vitále Silver Calcium Alginate wound dressing that still contained uncleared claims. 2. **Failure to establish and maintain design control procedures (21 CFR § 820.30):** Lack of procedures for design inputs, outputs, verifications, validations, reviews, transfers, changes, and a design history file. 3. **Failure to control design changes (21 CFR § 820.30(i)):** Numerous undocumented design