Ronald G. Crystal, M.D. New York, NY (9/23). Inspected 4/17-4/24. Clinical studies violations: Failed to follow the protocol by enrolling subjects who did not satisfy the eligibility criteria. Investigator administered the investigational product to subjects who should have been excluded. Investigator also failed to follow the time intervals for treatments specified in the protocol. Records of the disposition of the test article (purged) were inadequate without including quantity received, quantity used, lot number, administration to subjects, and the amount of stock remaining, etc. (investigational drug study); 21CFR 312.60, 312.62(a)(b) (CBER-02-015).
Drogueria Central Toa Baja, PR (10/17). Inspected 8/13-16/02. Misbranded: Firm has distributed Extra Strength Tylenol products bearing labels and labeling in Spanish only to a New York, NY for distributor for sale in the United States. (Tylenol products); FDCA 502(c), 21CFR 201.15(c)(1) (SJN-03-02)
Health Care Manufacturing Inc. Springfield, MO (10/18). Inspected 9/3-6/02. QSR deviations, adulterated: Company failed to establish procedures for management with executive responsibility to review the suitability and effectiveness of the quality system at defined intervals and with sufficient frequency to ensure that the system satisfies the requirements. Company does not possess procedures for implementing corrective and preventive actions that include requirements to analyze work operations, quality audit reports, and other sources of quality data to identify existing and potential causes of nonconforming product, or other quality problems. Documentation of testing and inspection after repairs is not included with service reports for X-ray systems, Masterstim muscle stimulators, or chiropractic tables, etc. (medical devices); FDCA 351(h), 21 CFR 820(c), 820.100(a), 820.198(a), 820.200(a), 820.200(d), 820.90(a), 820.20(e), 820.184(d) (KAN 2003-01)
70 Guafenesin manufacturers/distributors (10/11). Unapproved drug: Single-ingredient extended release dosage form of guaifenesin drug products must be approved under an NDA or ANDA. FDCA 505(a) (No Code)