Inspections, Compliance, Enforcement, and Criminal Investigations
First Quality Hygenics, Inc. 28-Jul-04
Department of Health and Human Services
Public Health Service
RETURN RECEIPT REQUESTED
July 28, 2004
Mr. Kambiz Damaghi
President and Treasurer
First Quality Hygienics, Inc.
North Road, Box 330
McElhattan, PA 17748
Dear Mr. Damaghi:
During an inspection of your establishment located in McElhattan, Pennsylvania, on March 30-31, 2004, our investigator determined that your firm manufactures tampons. Tampons are devices as defined by section 201(h) of the Federal Food, Drug, and Cosmetic Act (the Act).
The above-stated inspection revealed that your Super Plus Absorbency Tampons, lot 03LP20-0, are adulterated under section 501(h) of the Act, in that the methods used in, or the facilities or controls used for, the manufacture, packing, storage, or installation are not in conformance with the Current Good Manufacturing Practice (CGMP) requirements for medical devices which are set forth in the Quality System regulation, as specified in Title 21, Code of Federal Regulations (CFR), Part 820. Significant deviations include, but are not limited to, the following:
Failure to establish and maintain procedures to control product that does not conform to specified requirements as required by 21 CFR 820.90. For example, this device, consisting of 178,200 tampons, failed your firm's formal lot release criteria for Syrngyna (absorbency) testing, as stated in your SOP [redacted]. Syngyna testing is a measure of the absorbency of a tampon as required by 21 CFR 801.430, and is the "governing variable on the acceptance of a lot" according to your own SOP [redacted].
Additionally, 21 CFR 801.430 sets forth a methodology for Syngyna testing which requires that manufacturers design and implement a sampling plan that ensures a confidence level of 90%, often referred to as the 90/90 rule. That is, the probability is 90% that at least 90% of the absorbencies of individual tampons (within a brand and type), rounded to the nearest 0.1 gm, is within the range of absorbency stated on the package label. Your finished product testing results for the referenced lot (03LP20-0) showed an upper value of 15 .3 grams and did not meet the 90/90 confidence level for Super Plus Absorbency tampons which has an absorbency specification and regulation requirement of 12.0-15.0 grams. The 15.3 grams absorbency falls within the next higher absorbency, Ultra Absorbency, per 21 CFR 801.430. Your own internal documents noted, [redacted] and [redacted]. However the non-conforming lot was released and distributed.
Initially, you had no documentation justifying the release of the lot in question.
After the investigator brought the release of the non-conforming lot to your
manager's attention, documentation was provided the following day of the inspection.
Your rationale for release of the non-conforming lot was based on your combining
sampling results of the referenced lot with six other control lots to bring
the absorbency test result within specification and regulation requirements
. The other control lots were manufactured on different shifts and on different
We acknowledge the receipt of your written response to the List of Inspectional
Observations (Form FDA-483), dated April 5, 2004. Your response to the Form
FDA-483 is inadequate in that your justification for releasing the nonconforming
lot, 03LP20-0, is based on an undocumented redefinition of the sample population
to include six other control lots produced on different days and shifts to get
the failed lot to fall within the 90/90 confidence level. This practice is unacceptable
and not statistically valid. For the referenced lot, your own finished product
testing revealed that the 90% Upper Tolerance Limit with 90% Coverage was 15.3
grams which was greater than the specification requirement of 15.0 grams.
Your Super Plus Absorbency tampons, lot 03LP20-0, are misbranded under section
502(a) of the Act, in that the labeled name for this device represents or suggests
that the tampons are adequate and effective for a Super Plus absorbency range
of 12.0-15.0 grams, which representation or suggestion is false or misleading
or otherwise contrary to fact. The finished product testing shows an upper value
of 15.3 grams of absorbency, which raises the tampons to the Ultra Absorbency
category (15-18 grams of absorbency).
This letter is not intended to be an all-inclusive list of deficiencies at
your facility. It is your responsibility to ensure adherence to each requirement
of the Act and regulations. The specific violations noted in this letter and
in the FDA 483 issued at the close of the inspection may be symptomatic of serious
underlying problems in your firm's manufacturing and quality assurance systems.
You are responsible for investigating and determining the causes of the violations
identif ied by the Food and Drug Administration (FDA). You also must promptly
initiate permanent corrective and preventive action on your Quality System.
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. Additionally, no premarket submissions for Class III devices to which the Quality System regulation deficiencies are reasonably related will be cleared until the violations have been corrected. Also, no requests for the Certificates to Foreign Governments will be approved until the violations related to the subject devices have been corrected.
You should take prompt action to correct these deviations . Failure to promptly correct these deviations may result in regulatory action being initiated without further notice. These actions include, but are not limited to, seizure, injunction, and/or civil money penalties. Please notify this office in writing within 15 working days of receipt of this letter, of the specific steps you have taken to correct the noted violations, including an explanation of each step being taken to prevent the recurrence of similar violations. If corrective action cannot be completed within 15 working days, state the reason for the delay and the time within which the corrections will be completed.
Your response should be sent to Richard C. Cherry, Compliance Officer, at U.S. Customhouse, Room 900, 200 Chestnut Street, Philadelphia, PA 19106.
Thomas D. Gardine
Philadelphia District Office