Request Expert

Expert was a California Food & Drug Investigator for 26 years enforcing federal GMPs and California health & safety codes. She has traveled throughout California inspecting a wide range of wholesale food, drug, and medical device manufacturers. She was responsible for license and registration issuance and denials. She prepared administrative, civil and criminal cases involved a wide range of issues from basic GMPS, to spring/bottled water/water hauler issues, to drug/medical device license denials. In most instances, she would issue a report to the firm at the conclusion of the the inspection citing deficiencies. She sometimes gathered evidence, swore out and executed search warrants and testified in state and federal cases. Inspection included, on occasion, (unpaid) consultative services to industry as well as working with outside consultants. Her home office was shared by local FDA inspectors, and she regularly consulted and coordinated with them.

She performed unannounced inspections of food, pharmaceutical, and medical device companies for compliance with California Health & Safety Code and federal good manufacturing practices. These inspections included label review and on occasion, review of records pertaining to input v. output. These inspections occasionally resulted in criminal, civil, or administrative actions.
This expert collected evidence, wrote reports, issued misdemeanor citations, made occasional arrests, prepared statement of facts, prepared and participated in search warrants, deposition and court testimony.

Expert researched labeling requirements before, during, and sometimes after the inspection for compliance with both California Health & Safety code and FDA requirements. She collected labels of finished product and compared them with raw ingredient labels and formulations to ascertain if there were undeclared ingredients, fictitious ingredients, and that there was justification for ingredients being in a particular order. The most frequent offenders were bakeries who sometimes switched suppliers without considering the effect on their labels. Most of the time, Expert would cite the deficiencies—some of which were deliberate—on her Report of Observations and work with the companies to bring them into voluntary compliance. Some of Mrs. Expert' most significant cases involved fraudulent use of the term "organic", false statement of geographical origin (e.g., "pure Napa valley"), false statement of product identity (e.g., "cherry pies" without cherries), and false ingredient statements.

With co-packers, her primary aim was to educate them about their responsibility as a co-packer to review clients' labels for compliance with the law. Many co-packers had the attitude that their job was simply to manufacture and label products for others and simply used whichever labels the client supplied. Expert persuaded one major co-packer to incorporate label review as part of their customer "package." Although the co packer initially thought it might drive away business, they ended up prospering and had to construct new, larger quarters and purchase larger, faster filling and labeling machines to handle the increase in business. Far from losing customers, the company found that most of their customers were not at all well-informed on labeling requirements, and that input into labeling statements was greatly appreciated. Expert worked with company personnel in reviewing labels until she felt they had been adequately trained.

Expert worked closely with both large and small manufacturers to bring labels into compliance with the law. This review encompassed truth-in-advertising, proper net weight declarations, and a review of formulas and the actual raw materials, such as premixes, to determine the presence of undeclared ingredients (including allergens), fictitious ingredients (sometimes inadvertent as a result of the switching of suppliers), and ingredient listing in descending order of predominance. Education of co-packers as to their responsibilities under food and drug law was a continuing responsibility.As part of her duties with the California Food and Drug Branch, Expert certified raw springs for use by the bottled water industry. This would start at the initial undeveloped site to determine if it qualified as a spring under state law. She would be called in by industry at various stages of development to document progress; the final stage would determine licensure. One of her cases involving license denial made it to the California Court of Appeals, in which the three justices unanimously agreed that the applicant did not qualify under state law to operate a private spring.As part of her duties in the Food and Drug Branch, Expert worked with various pharmaceutical and medical device companies to enable them to obtain licensure under the California Health & Safety Code, or for license renewal purposes. Two frequent issues she encountered were (1) failure to comply with the firm's own SOPs, and (2) failure to calibrate in the range commonly used in manufacture.As a service to private industry, Expert would be called to a potential site to offer input if it was suitable for the operating of a wholesale manufacturing or reprocessing facility before the signing of a lease. More than one site was declared to be unsuitable, with others requiring modification for manufacturing purposes. Reviews of plan checks for proposed manufacturing sites were also done as part of her routine duties.A large, nationally known cannery was experiencing problems with spoilage of their canned juices. Expert identified several areas of potential contamination. One area involved the failure to clean air circulation fans. The other area was failure to calibrate the juice temperature recorder against a mercury standard. The firm addressed her concerns, and the problem was solved.