Inspections, Compliance, Enforcement, and Criminal Investigations
Pascal Company, Inc. 24-May-05
Department of Health and Human Services
Public Health Service
May 24, 2005
RETURN RECEIPT REQEUSTED
In reply refer to Warning Letter SEA 05-22
David E. Watton, President
Pascal Company, Inc.
2929 NE Northrup Way
P.O. Box 1478
Bellevue, Washington 98009
Dear Mr. Watton:
The Food and Drug Administration (FDA) conducted an inspection of your establishment located at 2929 NE Northrup Way, Bellevue, Washington, on December 6-9, 13-14, 20, 2004. Our investigators determined that your establishment operates as a manufacturer and distributor of liquid chemical sterilants/high level disinfectants, which are medical devices as defined by Section 201(h) of the Federal Food, Drug, and Cosmetic Act (the Act). At the conclusion of the inspection, a Form FDA 483, Inspectional Observations was issued to you.
Our review of information collected during the inspection determined that while you received a 510(k) premarket notification on May 27, 2003, for your Banicide Advanced 3.5% Glutaraldehyde Disinfection and Sterilization Solution, you have since changed the anti-corrosive agent in your formulation from [redacted] to Sodium Nitrite. In October 2003, you began testing the new formulation of Banicide Advanced with Sodium Nitrite. A premarket notification submission is required when significant modifications are made to a 510(k) cleared device under 21 CFR 807.81(a)(3). This can be accomplished via a Special 510(k).
In addition, the inspection revealed that your devices 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:
1. Procedures to verify the design of the device were not established or maintained [21 CFR 820.30(f)]. Specifically, design control procedures have not been established by our firm. You have changed the anti-corrosive agent for Banicide Advanced from [redacted] to Sodium Nitrite in the formulation of this product. This change was made to improve the stability of the product. The stability data do not support the minimum specification of [redacted]% Glutaraldehyde at a one year shelf life stored at room temperature. Furthermore, your firm has not collected data to demonstrate that your product meets a minimum specification of [redacted]% Glutaraldehyde at holding temperatures of up to 30°C.
2. Failure to establish and maintain procedures to ensure that the device history records (DHR's) for each batch, lot, or unit are maintained in order to demonstrate your firm's medical devices are manufactured in accordance with the device master record [21 CFR 820.184]. Specifically, a production employee changed the Master Formula & Batch Production Record for Banicide Advanced, Item Number 90-011 (Revision: 8/27/2003) for batch numbers BC100204 and BC100304. This employee added [redacted] liters of [redacted]% Glutaraldehyde Concentrate to the calculated formula, but there was no documentation to show this change had been approved by the Quality Control Unit (QCU).
3. Process validation activities and results have not been documented [21 CFR 820.75(a)]. Specifically, your procedure P3-VAL-004 (Revision: 3.0 8/20/03), titled "Validation of Banicide/Banicide Advanced Manufacturing Process," required that each sample be tested for the level of Glutaraldehyde and pH in duplicate. There is no documentation to show that each validation sample taken for batch numbers BC100104, BC100204, and BC100304 were tested in duplicate.
This letter is not intended to be an all-inclusive list of deficiencies at your facility. It is your responsibility to ensure adherence to all applicable FDA regulations and the Act.
You should take prompt action to correct these violations. Failure to correct these violations promptly 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 money penalties. Federal agencies are advised of the issuance of Warning Letters regarding devices so that they may take this information into account when considering the award of contracts.
You should notify this office within fifteen (15) working days from receipt of this letter of the specific steps you have taken to correct the noted violations, including an explanation of each step 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.
Please send your reply to the Food and Drug Administration, Attention: Lisa M. Elrand, Compliance Officer, 22201 23rd Drive SE, Bothell, Washington 98021-4421. If you have questions regarding any issue in this letter, please contact Lisa M. Elrand at (425) 483-4913.
Charles M. Breen