FDA WARNING_LETTER - Huestis Machine Corporation - May 13, 2013

On August 6, 2013, the FDA issued a Warning Letter to Best Medical International following an inspection from April 23 to May 13, 2013, at their Bristol, Rhode Island facility. The inspection revealed that the firm's X-ray collimators, radiotherapy simulators, and Universal Urology Exam Chairs/Tables are adulterated under section 501(h) of the Act, as their manufacturing processes do not conform to the Quality System (QS) regulation (21 CFR Parts 820 and 1002).

Key violations include: 1. **Equipment Requirements (21 CFR 820.70(g)):** Lack of installation documentation for the (b)(4) system used for Collimator Leakage Testing. 2. **Complaint Handling (21 CFR 820.198(a)):** No specific procedure for consumer complaints; 18 of 53 reports were performance issues that should have been complaints, including one involving collimator blades opening during exposure. Responsibilities for complaint, MDR, and CAPA determinations are undefined. 3. **Acceptance Activities (21 CFR 820.80(e)):** In-process inspection records for collimators were pre-filled with passing results before testing. 4. **Device History Record (DHR) (21 CFR 820