Inspections, Compliance, Enforcement, and Criminal Investigations
Galaxy Medical Inc 14-Jan-03
Department of Health and Human Services
Public Health Service
VIA CERTIFIED MAIL
January 14, 2003
Carl W. Wallman, President and Owner
Galaxy Medical Inc.
4700 West Prospect Road
Fort Lauderdale, Florida 33309
Dear Mr. Wallman:
The Food and Drug Administration (FDA) inspected your medical gas facility located, at the above address on September 24-25, 2002. Medical gases are drugs as defined by section 201 (g) (21 U.S.C. 321 (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 (21 CFR), Part 210 and 211, These deviations cause the medical Oxygen USP you transfill to be adulterated within the meaning of section 501(a)(2)(B) (21 U.S.C.351(a)(2)(B)) of the Act, in that the methods used in, or the facilities or controls used for, their manufacturing, processing, packing, storage, or holding, are not in compliance with CGMP.
The deviations include the following:
1. Failure to establish and implement scientifically sound and appropriate procedures to assure that your drug products conform to standards of identity, strength, quality, and purity as required by 21 CFR 211.160. Your firm has not established any written testing program or product specifications. Available written procedures fail to identify and define the pre-fill, fill, and post-fill checks to be performed on Oxygen USP cylinders filled at your facility.
2. Failure to conduct appropriate laboratory determination of conformance to final specifications including the identity and purity of Oxygen USP prior to release of transfilled cylinders for distribution, as required per 21 CFR 211.165. The [redacted] analyzer is not an acceptable test device for oxygen purity analysis in that the accuracy of the device is not equivalent to the USP test accuracy of +/-0.1%. The manufacturer's specifications list the [redacted] analyzer accuracy at +/-2% and identifies that the unit is not intended for testing oxygen from high pressure cylinders.
3. Failure to properly assay at least one cylinder per each uninterrupted filling sequence for both identity and strength [21 CFR 211.160(b)(4)]. A lot is defined as a manifold filling sequence or any uninterrupted filling sequence provided that the same equipment, personnel and lot of bulk is used. In addition, your firm failed to conduct all appropriate pre-fill, fill, and post fill checks on Oxygen USP cylinders transfilled at your facility.
4. Failure to test each component lot of bulk compressed oxygen to determine conformance with appropriate specifications prior to use, or in lieu of such testing, receive a valid certificate of analysis for each lot from your supplier and conduct an identity test as required by 21 CFR 211.84(d)(2).
5. Failure to establish written procedures describing the responsibilities and authorities of the Quality Control Unit (QCU) as required by 21 CFR 211.22. You have no written procedures for a QCU, nor do you have a defined QCU established at your facility. In addition, your production and control records are not reviewed by a QCU, in accordance with 21 CFR 211.192.
6. Failure to routinely calibrate mechanical and electronic equipment used in the transfilling of Oxygen USP or keep records of calibration according to a written program designed to assure proper performance as required by 21 CFR 211.68. For example, there was no documentation that your thermometer and the pressure gauges for the manifold filler have ever been calibrated.
7. Failure to establish and implement an effective employee CGMP training program. There was no documentation which demonstrates that any of the employees involved in the transfilling and storage of Oxygen U.S.P. have received training in current good manufacturing practices [21 CFR 211.25(a)].
8. Failure to establish adequate batch production and control records for each batch of drug product, including documentation that each significant step in the filling operation was performed [21 CFR 211.188]. The batch records from January 2002 until May 2002 are inadequate in that it is unacceptable to use a single entry to indicate that all or multiple required steps in the operation were performed. The batch records dated since May 8, 2002 do not document all required pre-fill, fill, and post-fill checks. For example, there is no hydrostatic test date examination. Your purity test result should also record the actual numeric assay value obtained with the Oxygen Analyzer rather than a checkmark [21 CFR 211.194].
9. Failure to have written procedures for handling all written and oral complaints regarding your drug products as required by 21 CFR 211.198.
10. Failure to establish written procedures designed to assure that correct labels and labeling are used, including identification of the drug product with a lot or control number that permits determination of the history of the manufacture and control of the batch [21 CFR 211.130(c)].
We acknowledge receipt of an undated package with your business card on October 10, 2002,that was submitted in response to the Inspectional Observations (Form FDA 483) issued at the conclusion of the above inspection. Your Oxygen Testing Procedure for New Shipments states that testing will be performed through use of a "paramagnetic type analyzer". However,the package includes a shipping document for a laser diode oxygen analyzer [redacted] Analyzer. The letter attached from the FDA regarding the [redacted] Analyzer states that firms using this analyzer are responsible for having a complete copy of the validation, data to demonstrate equivalency to the official USP Orsat burette test method. No validation data was included with your package for the [redacted] oxygen analyzer. No calibration procedure for the oxygen analyzer was provided with the oxygen analyzer calibration form.
Your package does not include product specifications or standards referenced in the SOPs. Your Labeling Procedure fails to establish any labeling issuance or reconciliation controls. This procedure also fails to establish a process where labeling materials are compared for identity and conformity to a master label. Your Pre-Fill Procedure should define how to conduct each pre-fill test. This procedure fails to correlate with the batch production record provided. For example, the record lists [redacted] tests but no such tests are listed in this procedure. We suggest you revise your filling procedures to define each pre-fill, fill and post-fill check by name to directly correlate to production records. Your Oxygen Cyclinder Procedure defines an uninterrupted filling sequence as [redacted] without clarifying that any additional filling cycles on the same day after any breaks or shutdowns in a filling process would require additional testing. Your Quality Control Procedure fails to define which personnel will be responsible for the quality control functions. All of the Galaxy Medical procedures are dated January 1, 2002, but were not in effect during our inspection. We are unable to determine which SOPs and forms have been implemented as submitted in your response. No written correspondence letter was provided addressing all of the cited deviations and, planned corrective actions. This response does not alleviate our concerns regarding the violations documented during our inspection.
The above identification of violations is not intended to be an all-inclusive list of deficiencies at your facility. lt is your responsibility to ensure adherence to all requirements of the Act and its implementing regulations. Federal agencies are advised of the issuance of all Warning Letters about drugs so that they may take this information into account when considering the award of contracts.
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.
Within fifteen (15) working days of receipt of this letter, please notify this office in writing of the specific steps you have taken to correct the noted violations and to prevent their recurrence. If corrective action cannot be completed within fifteen (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: Shari J. Hromyak, Compliance Officer, 555 Winderley Place, Suite 200, Maitland, Florida 32751. If you have questions regarding any issue in this letter, please contact Ms. Hromyak at (407) 475-4730.
Emma R. Singleton
Director, Florida District