Inspections, Compliance, Enforcement, and Criminal Investigations
Keeler's Medical Supply, Inc. 02-Aug-05
Department of Health and Human Services
Public Health Service
August 2, 2005
VIA CERTIFIED MAIL
RETURN RECEIPT REQUESTED
In reply refer to Warning Letter SEA 05-28
Charles E. Vetsch, President
Keeler's Medical Supply, Inc.
2001 West Lincoln Avenue
Yakima, WA 98902
Dear Mr. Vetsch:
The Food and Drug Administration (FDA) conducted an inspection of your medical oxygen facility located at 2001 West Lincoln Avenue, Yakima, Washington, on March 15-17, 2005. Medical oxygen is a drug as defined by section 201(g) of the Federal Food, Drug, and Cosmetic Act (the Act).
Our inspection found significant deviations from the Current Good Manufacturing Practice (CGMP) regulations for drug products, set forth in Title 21, Code of Federal Regulations, Parts 210 and 200 (21 CFR 210 and 211). These deviations cause your product, medical oxygen, to be adulterated within the meaning of 21 U.S.C. 351(a)(2)(B) (Section 501(a)(2)(B) of the Act), in that the methods used in or the facilities or controls used for the manufacturing, processing, packing, storage or holding of your product are not in conformance with CGMP regulations.
Our inspection found the following deviations from CGMP regulations:
1. Failure to perform testing to determine satisfactory conformance to final specifications for the finished drug product, including identity and strength of the active ingredient, prior to release [21 CFR 211.165(a)].
For example, finished product testing is not performed on filled cylinders of Oxygen Compressed USP, prior to their release for distribution. From August 2004 to March 2005, you released hundreds of lots of Oxygen Compressed USP without testing the product for identity and strength. In addition, finished product odor tests are not performed as required by the Oxygen USP monograph.
2. Failure to establish scientifically sound and appropriate specifications, standards, sampling plans and test procedures designed to assure that drug products conform to appropriate standards of identity, strength, quality, and purity. [21 CFR 211.160(b)].
For example, your firm's written procedures do not address the methods to be used for testing finished drug products. There were no written procedures for operation of the [redacted] Oxygen Analyzer. There were no written procedures for calibration of this instrument as required by 21 CFR 211.160(b)(4).
3. Failure to perform adequate filling operations on each high pressure cylinder, prior to filling [21 CFR 211.84(d)(3)].
For example, the heat of compression fill check is not conducted by your firm.
4. Failure to routinely calibrate automatic or mechanical equipment according to a written program [21 CFR 211.68(a)].
For example, there was no documentation to show that your vacuum gauges for the oxygen manifold system have been calibrated. Use of vacuum gauges assures removal of any foreign or residual gas. Also, the calibration of the thermometer used to monitor the medical oxygen transfilling process was not performed by your firm.
5. Failure to establish a Quality Control Unit (QCU) having the responsibility and authority to approve or reject all components, drug product containers, closures, in-process materials, packaging materials, labeling, and drug products and the authority to review production records to assure that no errors have occurred [21 CFR 211.22(a)]. Failure to have written procedures defining the responsibilities of the QCU unit [21 CFR 211.22(d)].
For example, your firm has not established a QCU. Personnel with QCU authority have not been appropriately designated. There are no written procedures defining its responsibilities or functions.
6. Failure to train employees in the particular operations performed or in current good manufacturing practice regulations as they relate to the employee's functions [21 CFR
For example, employees have received no training in current good manufacturing practice regulations. Both management and staff professed to be unaware of applicable cGMP requirements when interviewed by the FDA investigator.
7. Failure to establish and follow adequate written procedures for production and process control designed to assure that drug products have the identity and strength they purport or are represented to possess [21 CFR 211.100(a) and (b)].
For example, you have not established detailed written procedures for the receipt, transfilling, storage, quarantine, and distribution of Oxygen Compressed USP. The general filling procedure used by your firm's filling personnel has not been reviewed and approved by a QCU. In addition, the filling procedure is deficient in that it does not require a finished product odor test or heat of compression test and other referenced procedures, such as those for equipment calibration and handling of incoming source cylinders are missing. Furthermore, your firm overfilled aluminum cylinders to 2200 psi. Aluminum cylinders should never be overfilled. This overfill potentially compromises the integrity of the aluminum cylinder, which could lead to the possible rupture of a cylinder. Your firm must utilize a temperature/pressure chart to ensure correct cylinder filling pressure and temperature values during filling of cylinders.
Additionally, we have reviewed your label for Oxygen Compressed USP and have the following comments:
"USP" is typically placed on the same line as the rest of the product name and in the same type size. Your label also includes the statement, "CAUTION: Federal law prohibits dispensing without a prescription". We recommend that you delete the statement "CAUTION: Federal law prohibits dispensing without a prescription" because that statement is no longer required. Instead, section 503(b)(4)(a) of the Act requires that the label bear, at a minimum, the symbol "Rx Only". We recommend that you place the "Rx Only" symbol immediately after the statement "For all other medical applications," to read: "For emergency use only when administered by properly trained personnel for oxygen deficiency and resuscitation. For all other medical applications, Rx Only". Under section 502(c) of the Act, the "Rx Only" symbol must be prominently displayed and should not be obscured by other statements on the label. Therefore, we recommend you move this statement to the top of the labeling information just underneath the "WARNING:" statement. A label example is enclosed.
The above identification of violations is not intended to be an all-inclusive list of deficiencies at your facility. It is your responsibility to assure adherence with each requirement of the CGMP regulations. Federal agencies are advised to the issuance of all Warning Letters about drugs so that they may take this information into account when considering the award of contracts. Please note that we will share our findings with the Department of Transportation. You should take prompt action to correct these violations, and you should establish procedures whereby such violations do not recur. Failure to do so may result in regulatory action without further notice. Possible actions include, but are not limited to, seizure and/or injunction.
You should notify this office in writing, within fifteen (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 taken to prevent 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 corrections will be completed.
Your reply should be sent to the Food and Drug Administration, Seattle District Office, 22201 23rd Drive SE, Bothell, Washington, 98021-4421, to the attention of Lisa M. Althar, Compliance Officer. Should you have any questions concerning this letter, you can contact Ms. Althar at (425) 483-4940.
Charles M. Breen