Pointcare Technologies, Inc – FDA Warning Letter, Apr 28, 2011

On June 14, 2011, the FDA issued a Warning Letter to Pointcare Technologies, Inc. following an inspection from March 25 to April 28, 2011. The inspection revealed that the firm's hematology in-vitro diagnostic products, including CD4NOW Gold reagents, are adulterated under 21 U.S.C. § 351(h) because manufacturing, packing, storage, or installation methods do not conform to Current Good Manufacturing Practice (CGMP) requirements of the Quality System (QS) regulation (21 CFR Part 820).

Key violations include: 1. **Failure to validate processes (21 CFR 820.75(a)):** The firm validated the CD4NOW Gold Reagent 0.400 mL process despite two of three validation lots failing specifications for osmolality and optical density, subsequently modifying acceptance ranges. The FDA found the firm's response inadequate, noting a lack of documentation to support process robustness and reproducibility, and that the Process Validation SOP (SOP-044 Rev A) lacks clear requirements for validation acceptance criteria. 2. **Failure to establish and maintain design validation procedures (21 CFR 820.30(g)):** The firm lacked documentation for reviewing and approving design input requirements, such as a 12-month expiry date for CD4NOW Gold Re