Ambco Electronics Tustin, CA (1/6). Inspected 10/4-10/10/03. QSR deviations, adulterated: Firm had no quality plan defining the quality practices, resources, and activities relevant to devices that are designed and manufactured. No quality system procedures and instructions were established and implemented. Firm also failed to establish and implement procedures for receiving, reviewing, and evaluating complaints by a formally designated unit and failed to establish procedures to control the design process of a device, etc. (automatic, semiautomatic, and manual audiometers); FDCA 501(h), 21CFR 820.20, 820.5, 820.22, 820.100, 820.198, 820.30, 820.40, 820.50, 820.75, 820.90 (W/L 18-04)

http://www.fda.gov/foi/warning_letters/g4478d.pdf

Custom Compounding Centers Little Rock, AK (12/23). Inspected 8/29/03. GMP deviations, adulterated, misbranded: FDA’s investigations determine that the firm exceeds the scope of the regular course of the practice of pharmacy and into the activities of a drug manufacturer. For example, it manufactures the (purged) product in anticipation of receiving prescriptions and then ships the kit to customers and fails to reconcile or account for the amount shipped with any prescriptions received from customers. FDA believes the firm is operating as a retail pharmacy engaged in extemporaneous compounding. The firm does not have a valid biologics license for its activator kits. Labeling fails to bear adequate directions for use, etc. (activator kits); FDCA 502(f)(1), 501(a)(2)(B), PHS 351(a), 21CFR 211.165(a), 211.166(a), 211.137(a), 211.100, 211.80, 211.170(b) (CBER-04-003)http://www.fda.gov/foi/warning_letters/g4474d.pdf