Inspections, Compliance, Enforcement, and Criminal Investigations
American I.V. Products, Inc. 19-Oct-05
Department of Health and Human Services
| Public Health Service |
Food and Drug Administration
|Central Region |
Baltimore District Office
6000 Metro Drive, Suite 101
Baltimore, MD 21215
Telephone: (410) 779-5454
FAX: (410) 779-5707
FEI : 1121996
October 19, 2005
VIA CERTIFIED MAIL
RETURN RECEIPT REQUESTED
Mr. Michael Banz, President
American LV . Products, Inc.
7485 Shipley Avenue
Hanover, Maryland 21077-3154
Dear Mr. Banz :
During an inspection of your firni located in Hanover, Maryland, beginning July 29, 2005 and ending August 17, 2005, our investigator determined that your establishment is a medical device manufacturer and distributor of the AIV Ultrasound Fetal Monitor Transducer, Models FM10833 and FM10834, which are medical devices as defined in section 201(h) [21 U.S .C . § 321(h)] of the Federal Food, Drug and Cosmetic Act (the Act).
The inspection revealed that these devices are adulterated within the meaning of section 501(h) of the Act [21 U.S.C. 351(h)], in that the methods used in, or the facilities or controls used for, their manufacturer, packing, storage, or installation are not in conformity with the current Good Manufacturing Practice (cGMP) requirements of the Quality System (QS) Regulation found in Title 21, Code of Federal Regulations (CFR), part 820. Significant violations of the QS Regulations documented in the form FDA 483 "Inspectional Observations" issued to Mr. Richard L. Stacey, Vice President of Marketing and New Product Development, at the close of our inspection included :
1. Your firm has failed to validate the processes used to manufacture your AIV Ultrasound Fetal Monitor Tranducers or failed to fully test and inspect each unit assembled. 21 CFR 820.75(a) Specifically, your firm does not have a validation protocol, and has not performed a process validation on the manufacturing process used to manufacture the transducers.
2. Your firm failed to establish and maintain procedures for validating the device design for your AIV Fetal Monitor Transducers. Specifically, you were unable to provide either a protocol or previously established acceptance criteria for this device to determine if your device conforms to user needs. 21 CFR 820.30(g)
3. Your firm failed to establish and maintain procedures for verifying that design output meets design input requirements. Specifically, the documentation of testing of the ultrasound transducers performed by [redacted] to determine if the design input meets the design output lacks a protocol or previously established acceptance criteria. 21 CFR 820.30(t)
4. Your firm failed to document the development of the difference in resistor requirements of the Fetal Monitor Transducer Board Assembly from the original design documents to the final design document. The original design document indicates the resistor requirements must test to 47 ohms, whereas the final design document indicates the resistor must test to 46.4 ohms . 21 CFR 820.30(c)
5. Your firm failed to follow procedures QSP-9001 8.3.1 "Control of Nonconforming Product Procedure" (Rev. A, 10/29/04), and QSP-8.3 .1 "Control of Nonconformances" (Rev. 0, 3/4/05) in handling products that did not conform to specifications. Specifically, our investigator noted out-of-specification testing results for crystals readings found in PCB boards which are used to manufacture fetal monitoring transducers. Your test procedures require a 200 mV test result or greater as stated in Work Instruction reference number 204 "FMT Test and Inspection Procedure" (rev. date 1/14/02). The testing results documented were less than 200 mV and no corrective actions were documented as being taken. Additionally, "Engineering Approval Forms" for the FMT PC Board Assembly (10579) were completed for lots #7823 (manufactured 6/9/05) and #8037 (manufactured 7/20/05) showing caliper measurements that were out of specification. No corrective actions were documented as being taken. 21 CFR 820.90(a)
6. Your firm failed to include in the device history record for FM10833 kits #102 (manufactured 3/10/05) through # 145 (manufactured 7/25/05) the labeling that is attached to the transducers and the final packaging. 21 CFR 820.184(e)
This letter is not intended to be an all-inclusive list of deficiencies at your facility. It is your responsibility to ensure adherence with applicable laws and regulations. Federal agencies are advised of the issuance of all Warning Letters about devices so that they may take this information into account when considering the award of contracts.
You should take prompt action to correct these deviations. Failure to promptly correct these deviations may result in regulatory action being initiated by the FDA without further notice. These actions include, but are not limited to seizure, injunction, and/or civil penalties.
Please notify this office in writing within fifteen (15) working days of receipt of this letter of the steps you have taken to correct the noted violations, including (1) the time frames within which the corrections will be completed, (2) any documentation indicating the corrections have already been achieved or are in progress, and (3) an explanation of each step being taken to identify and make corrections to any underlying systems problems necessary to assure that similar violations will not recur. We also acknowledge receipt of your October 3, 2005 response to the FDA-483 and are in the process of reviewing that correspondence.
Your response should be sent to: Elizabeth A. Laudig, Compliance Officer, Food and Drug Administration, 6000 Metro Drive, Suite 101, Baltimore, MD 21215. If you have any questions, please do not hesitate to contact Ms . Laudig at (410) 779-5441.
Michael W. Roosevelt
Acting District Director