Shoney Scientific India – FDA Warning Letter, Aug 20, 2010

On January 20, 2011, the FDA issued a Warning Letter to Shoney Scientific India following an inspection from August 17-20, 2010, at their Pondicherry, India facility. The inspection determined that the firm manufactures various medical devices, including Biopsy Punches and Liposuction Cannulas, which are subject to the Federal Food, Drug, and Cosmetic Act.

The inspection revealed that the devices are adulterated under section 501(h) of the Act because the manufacturing, packing, storage, or installation methods and controls do not conform to the Current Good Manufacturing Practice (CGMP) requirements of the Quality System (QS) regulation (21 CFR Part 820).

Specific violations include: 1. **Failure to adequately validate processes (21 CFR 820.75(a)):** The heat sealing process for sterile packaging of Disposable Biopsy Punches, using Equipment # (b)(4), has not been validated. 2. **Failure to establish and maintain adequate procedures for finished device acceptance (21 CFR 820.80(d)):** Final device acceptance procedures do not require review of ETO Sterilization Certification for biopsy punch products prior to release for distribution, citing examples like Sterilization Lot # (b)(4) (July 19, 2010) and Lot # (b)(4) (June