MEDICAL DEVICES.

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Alfa Scientific Designs, Poway, CA, June 4 (Los Angeles). In an unusual move, FDA released this untitled letter, which stated that the April 17-25 inspection disclosed deficiencies that "would warrant a warning letter if not corrected." The untitled letter added that Alfa's May 2, 11 and 25 responses to the 483 had "satisfied us that you either have taken or are taking appropriate corrective actions" for unspecified deviations from GMPs. The agency noted that the findings would not affect pending premarket submissions or certificates for export.

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AMDL Inc., Tustin, CA, June 6 (Los Angeles). The warning letter cited the maker of unidentified in vitro diagnostics for lack of documentation "describing any internal activities conducted by your firm for the years 2000 and 2001 to determine" the firm's quality system's compliance with QS regulations and for a quality system that referred to responsibilities "for positions that do not exist, such as a quality systems manager." The agency informed AMDL that failure to promptly correct the deviations may result in further regulatory action, including seizure, injunction and/or civil penalties. The unnamed investigator audited the firm April 19-20. QC/QS

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Biomet, Warsaw, IN, June 8 (Detroit). The heavily-purged warning letter cited an unidentified subsidiary's production of disposable infusion pump kits for design control documentation that failed to "describe the overall design and development planning process." FDA said Biomet also lacked documentation that inside and outside diameters of a flow restrictor were evaluated to assure adequate sealing. FDA cited the firm's validation for failing to include a worst-case scenario for "tolerance stack-ups" and noted that an Oct. 17 investigation into an out-of-specification outcome for flow restriction was open at the time of the inspection. The agency added that Biomet's subsidiary removed a requirement to measure the inside diameter of incoming flow restrictors in November 2000 because flow restrictor assemblies were "100% flow tested." FDA added that the relevant procedure was not revised to call for inspection of incoming flow restrictors, nor approved, until Jan. 14, 2001. The letter noted that the employee acting as the quality control manager also served as the engineering manager. The inspection of the unnamed entity took place Jan. 22-26. CAPA, Design, Val

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Foredom Electric, Bethel, CT, May 22 (New England). FDA cited the maker of powered percussors, described as intended to "transmit vibration through a patient's chest wall to aid in freeing mucus," for labeling that failed to indicate that use of the device required a prescription by a physician, dentist or veterinarian. The letter stated Foredom did not restrict sales to qualified practitioners or those with a prescription and that indications for use were not included in product literature. The agency inspected Foredom Jan. 10. Lab

The following symbols are used to flag certain warning letters containing alleged violations of specific FDA regulations and policies of current interest:

BSE   Violation of regulations controlling for Mad Cow disease (bovine
spongiform encephalopathy)
Cal   Calibration
C-H   Complaint handling
CAPA   Corrective and preventive action
Design   Design validation activities
DSHEA   Labeling that exceeds 'structure/function claims for dietary
supplements
F-I   Lack of failure investigations
LAB -- Labeling issues
MDR   Medical Device Reporting
NLEA    Labeling that violates the Nutritional Labeling and Education Act
PMA   Lack of premarket approval
QC/QS   QC/quality systems deviations
S-HACCP   Violations of HACCP requirements for seafoods
Stab   Stability
Ster   Sterility
Val   Validation
Web   Internet promotion irregularities

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Joel Kaplan, M.D., San Diego, CA, June 11 (CDRH-OC). FDA's cited Kaplan's Web site promoting the MegaVac, a device intended to create and maintain penile erection in impotent men, for containing "the same unacceptable claims for penis enlargement and/or correction of penis curvature" that the agency cited in an August 2000 review. FDA told Kaplan that the statement the MegaVac involved "virtually no side effects" should be replaced with "side effects are infrequent and minor and can be minimized by not misusing the device." The letter informed the physician that the claim of "no side effects" required a PMA. FDA said MegaVac was cleared via a 510(k). Web

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Nicolet Biomedical, Madison, WI, May 24 (Denver). The agency wrote that its inspection of Nicolet Vascular of Golden, CO, which makes ultrasound units for vascular and obstetrical uses, disclosed the company repaired and returned two units without "any evidence that failure investigations" were conducted. The letter stated that Nicolet Vascular lacked any statistical rationale for release of products because the relevant procedure did not "provide for a sample size correlating to the lot size being tested," and that audit procedures did not define the areas of operation to be evaluated and did not specify "Who represent(s) appropriate members of the audit team." FDA acknowledged Nicolet's April 4 reply to the 483 and advised that premarket submissions and certificates of export would be withheld pending certification by a consultant. Investigator Lori Lahmann inspected Nicolet March 19-28. C-H, F-I

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Prosec Security Systems, Lakewood, NJ, June 8 (New Jersey). The maker of umbilical cord clamps with security transponders was cited for failure to establish and implement a quality system and for lack of procedures for CAPA. FDA stated that an umbilical cord clamp was redesigned by a supplier but that Prosec did not document appropriate design controls and that the ethylene oxide sterilization procedure was not validated to assure a sterility level of "10-6." The letter contended that "employees used the manufacturing area as a lunchroom" and commented that FDA had received no written reply to the 483. The unnamed investigator inspected Prosec May 10-11. Design, E-M, QC/QS

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Telstar Innovations, Oakford, PA, June 11 (CDRH-OC). FDA stated that the firm's Web site for the Qi-Gong, a therapeutic vibrator, claimed the device could ease pain and disperse stagnation, helping to prevent and treat diseases and conditions such as macular degeneration and palpitations in violation of the device's cleared claims. The letter added that a Web site for the TDP device??? Explain the acronym, and an infrared lamp, claimed the device could treat bone injury and prostatitis, also in violation of approved claims. PMA, Web

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Wright Medical Technology, Arlington, TN, April 11 (CDRH-OC). FDA reiterated its opinion that the firm's Allomatrix human demineralized bone matrix putty required premarket approval. The warning letter made reference to an August meeting between the firm and FDA. PMA