Feel Tech Bio Co., Ltd – FDA Warning Letter, Nov 22, 2012

On November 19-22, 2012, an FDA inspection of Feel Tech in Cheonan-si, South Korea, revealed that their insulin syringes and needles, classified as devices, were adulterated under 21 U.S.C. § 351(h). The manufacturing, packing, storage, or installation methods did not conform to the Quality System (QS) regulation (21 CFR Part 820).

Key violations include:

1. **Failure to establish and maintain CAPA procedures (21 CFR 820.100(a)(3)):** The firm did not adequately identify actions to prevent recurrence of dislodging needles from Accusure Insulin Syringes, evidenced by multiple recalls without clear rationale for scope. Sterilization revalidation issues due to personnel changes were not addressed at root cause. The firm's response was inadequate, lacking evidence of implemented corrections or a retrospective review of CAPAs.

2. **Failure to investigate nonconformities (21 CFR 820.100(a)(2)):** Investigations into dislodging needles lacked documentation and support for conclusions. Further instances of needle dislodging in November 2009 had no documented investigation or CAPA. The firm's response was inadequate, not committing to investigations or retrospective CAPA reviews.

3. **Failure to validate processes (21 CFR 820