Investigators' Reports

Device Firm Closes Pending Compliance with FDA Regulations

After FDA found manufacturing problems with sensitive eye treatment devices, a device firm and two of its officers agreed to stop operating until FDA requirements are met.

U.S. District Court Judge Robert E. Keeton of the District of Massachusetts in Boston last April 25 entered a consent decree of permanent injunction against Mira Inc., of Waltham, Mass., and Luc Schepens and Roger O'Brien. Schepens was Mira's president, and O'Brien its manager of quality assurance, quality control, and regulatory affairs.

The firm specializes in devices such as cryogenic probes used to freeze eye tissue for surgery and sterile implants used to reattach detached retinas. The government's complaint for injunction filed with the consent decree alleges that the devices violated FDA's good manufacturing practice (GMP) regulations since at least 1991.

FDA inspections of Mira since 1986 had revealed numerous GMP deficiencies. In a regulatory letter dated Feb. 20, 1991, the agency's Boston district office advised Mira of problems with implants, such as inadequate controls for specifications and quality assurance, uninvestigated complaints, inadequate record keeping, unclean conditions, and no written procedures for finished device inspection.

Further, FDA advised, Mira hadn't reported to the agency complaints about a laser and a glaucoma device. A health-care professional complained, for example, that filters didn't protect the operator from possible injury from reflected laser beams. If Mira did not act promptly to make corrections, FDA warned, the agency might invoke legal actions such as seizure or injunction. Mira promised corrections.

Then, between November 1991 and December 1992, complainants told FDA's Boston office that the deficiencies with the agency's GMP regulations were continuing at the firm.

Following these complaints, FDA investigators inspected Mira and found additional evidence of continuing violations. A 1992 inspection revealed the firm was marketing a device without FDA clearance. Mira voluntarily recalled the device.

During a March and April 1993 inspection, FDA engineer Richard Wright observed practices relating to violations of GMP regulations in the manufacture of Mira's Imex silicone implants and cryogenic freezing instruments.

Mira buys Imex strip and sponge implants ready-made and cuts them to size. But the firm itself molds a third Imex variety, silicone tire implants (so-named because of their tire shape), from purchased raw material--a medical grade elastomer.

Information included with the elastomer indicated a shelf life of only six months, Wright found, yet Mira was using elastomer produced in 1987 to make the tire implants.

Wright found Mira had lost the elastomer's original certificate and had the material tested only once, in September 1992. During that test, Wright learned, the material failed the firm's own specifications for tensile strength and elongation and wasn't tested for another specification.

Also, Wright found Mira made a design change in its cryogenic devices but never tested the new products to make sure they worked properly. "The change in fact caused them to fail," he says, "so Mira had to go back to the original design."

Wright informed Mira of his findings.

In a letter dated April 30, 1993, Mira told FDA it planned to take corrective action "as logistical and manpower limits allow."

In July and August 1994, Wright and investigator John McCann inspected Mira.

"Mira was not operating in a state of control," Wright says. "The GMP problems were systemic, and the corrective actions didn't address the root causes. Therefore, each time we'd go in, we'd invariably find similar problems."

As a result of this inspection, FDA requested a permanent injunction.

Under the consent decree, Mira and its officers Schepens and O'Brien agreed to:

• stop making and shipping medical devices until the company complies with FDA's GMP regulations
• undergo FDA reinspection to ensure practices comply with the law before resuming full operation
• destroy devices that can't be brought into compliance with the Federal Food, Drug, and Cosmetic Act
• maintain compliance with laws and regulations enforced by FDA
• hire an expert consultant to conduct audits during the next two years to ensure operations continue to meet FDA's GMP regulations.

Dixie Farley is a staff writer for FDA Consumer.

Bribery Attempt Lands Businessman in Jail

The importer, Phillip Chew, 38, owner of Wha Shing Trading Co., was sentenced June 13, 1995, in U.S. District Court for the Northern District of California to four months in prison, followed by four months of electronic home monitoring and three years' probation for bribing FDA investigator Junes Valdemoro of FDA's San Francisco district office. He also was fined $5,000.

Chew had hoped to sway Valdemoro into allowing possibly contaminated food from China into the country.

Acting on what he learned in a mandatory training course, Valdemoro enabled the Department of Health and Human Services' Inspector General's Office of Investigations to conduct a sting operation that led to Chew's conviction. Valdemoro assisted in the sting operation.

Chew initially offered Valdemoro money on May 4, 1994, at his Chinatown business, after Valdemoro rejected the entry of food whose packaging was covered with rodent droppings.

Chew told Valdemoro he would clean it up and then left the room. When he came back, Valdemoro recalled, Chew held out a wad of money to him.

"I told him, 'No, no, that's illegal,' but he was persistent," Valdemoro said. "He told me that it was a Chinese New Year present and that I was his friend. Then I remembered what I learned in training: that I shouldn't close the door on this guy. So I said, 'I'll have to think about this.'"

Valdemoro then left the premises and called his supervisor and the Office of the Inspector General (OIG) in San Francisco. At the OIG's request, he participated in plans to secretly monitor his future dealings with Chew. Officials briefed Valdemoro on what he should do and say on subsequent visits and arranged for him to be wired for secret audiotaping.

As directed by the OIG, Valdemoro contacted Chew later that day. Chew offered him $300 in return for a "clean report." Valdemoro accepted the money and turned it over to the OIG for use in its investigation.

Valdemoro returned to Chew's warehouse on May 19 for a routine examination of a Customs entry. While Valdemoro was there, Chew put a $100 bill into Valdemoro's lab coat and said it was a gift. Again, Valdemoro accepted the money and turned it over to the OIG.

That same day, Chew offered to pay Valdemoro $200 to $500 to release seven food items detained by FDA because of contamination with insects, animal filth, feathers, rat or mouse hair, cat or dog hair, and rabbit hair. One item had to be relabeled to include sulfites as an ingredient. No money was exchanged.

On May 23, Chew gave Valdemoro $1,000 to have the seven food items released, and on Aug. 17 gave him $900 to release another detained entry. Valdemoro again gave the money to the OIG. The detained items were never released for sale in this country. Chew also offered to give Valdemoro a pager and cellular phone to simplify future illegal transactions.

Chew and a business partner, Ada Lee, were arrested Oct. 13 for bribing a government official. Chew pleaded guilty to one count of bribery. The U.S. Department of Justice did not seek prosecution of Lee.

For his exemplary work, Valdemoro received the DHHS Inspector General's annual Integrity Award last August.

--Paula Kurtzweil

Seafood Maker Fined For Misbranding

But little or no crab meat was in many of those products. Instead, the shells were stuffed with surimi, a whitefish sometimes used as an inexpensive crab substitute, which should have been listed on the label.

As a result of fraudulent use of the word "crabmeat," David R. Carrington and his company, Carrington Foods Inc., of Saraland, Ala., were ordered to pay $78,000 in fines last May 15 after pleading guilty to one misdemeanor count and one felony count of food product misbranding.

Carrington, 50, also was sentenced to two years' probation, and his company received five years' probation. Initially, Carrington was indicted on a felony misbranding charge, but when he agreed to plead guilty, the court downgraded the charge to misdemeanor, while retaining the felony charge for his company.

FDA first became aware of Carrington's misdeeds in late 1993, when a seafood industry consultant told FDA investigators that Carrington Foods was not putting any crab meat in its stuffed crabs. (FDA considers stuffed crabs without crab meat to be "imitation stuffed crabs.") In response, FDA collected numerous samples of Carrington's products and confirmed that little or no crab meat was present.

In late November and early December 1993, investigators from FDA's Mobile, Ala., resident post inspected Carrington Foods and observed its manufacturing procedures. At the beginning of the inspection, investigators noticed more than 1,100 pounds of frozen surimi being thawed in the firm's production areas. Within three hours, plant employees placed the surimi in one of the company's large coolers, where it remained for the rest of the inspection.

Investigators observed Carrington's production of stuffed crabs for Sam's Club. The firm used minced crab meat, an inexpensive "mushy" product with little or no texture, unlike the chunky texture normally seen through package windows in Miss Sally's stuffed crabs. But because minced crab is a crab product, the plant appeared to be processing the food legally. Analysis of a stuffed-crab sample produced during the inspection revealed some crab meat but no surimi.

After the inspection, FDA's Nashville district office requested more samples of Carrington Foods' stuffed crabs. Samples analyzed in FDA's Seattle laboratory showed Carrington had been substituting surimi for crab meat before the 1993 inspection, was using minced crab meat during the inspection, and then switched back to surimi after the inspection.

Because the samples clearly documented consumer fraud, in April 1994 the agency's Office of Criminal Investigations began working with the U.S. Attorney's Office to bring charges. In December 1994, a grand jury indicted Carrington and his firm on misbranding charges.

Carrington Foods has since lost its contract with Sam's Club.

--John Henkel

Defective Lenses Reconditioned

At press time in August, FDA expected Mentor ORC Inc., formerly Optical Radiation Corp. (ORC) of Azusa, Calif., and Cidra, Puerto Rico, to complete the reconditioning process in October. ORC agreed to recondition the lenses, worth as much as $20 million, after numerous FDA inspections found that they were not made in compliance with good manufacturing practices (GMPs). The lenses were among 92,000 seized in 1993 because of possible defects.

The U.S. District Court for the Central District of California entered the consent decree on July 5, 1994, and ORC sold its IOL business to Mentor Corp. of Santa Barbara, Calif., a few months later. Mentor renamed the company.

Following surgery to remove cataracts, the IOLs are permanently placed in the eyes of patients, who are typically at least 60 years old. Defective IOLs pose an unreasonable risk to patients because damaged IOLs can impair sight and injure tissue, leading to the need for more surgery. Surgery may be especially risky in older people, who may have other health problems.

FDA first uncovered GMP violations during a routine inspection of the company's Puerto Rico facility in 1989. (The IOLs were made in San Juan and then shipped to California for sterilizing and packaging.) Violations continued to show up during inspections in 1991 and 1993, despite an FDA warning and notice of adverse findings. Most of the violations were at ORC's Puerto Rico facility, although an inspection of the company's California plant in 1993 also uncovered deficiencies.

The inspections found that, among other things, the company failed to:

• establish and carry out measures to ensure the devices were made according to design plans
• adequately investigate physicians' complaints about the IOLs
• validate certain manufacturing processes
• investigate the reasons for high defect rates.

Posting a $1 million bond, the company agreed to recondition the lenses, dispose of those that failed reinspection, and pay the federal government up to $56.50 an hour for FDA to supervise the process, which began early this year.

The company was reconditioning the lenses at its Puerto Rico facility and plans to move its entire IOL business to that site in the near future.

--Paula Kurtzweil

FDA Consumer magazine (November 1995)