|Company:||Quick-Fill Mobile Oxygen, Inc.|
|Subject:||CGMP for Finished Pharmaceuticals/Adulterated|
|Issuer:||New Orleans District Office|
|Issued:||Dec. 8, 2006||Closed:||
Department of Health and Human Services
Public Health Service
New Orleans District
December 8, 2006
WARNING LETTER No 2007-NOL-08
Mr. Timothy G. Ditmore, Owner
Quick-Fill Mobile Oxygen Inc.
10521 River Road
Gulfport, Mississippi 39503
Dear Mr. Ditmore:
On August 14, 15, and 18, 2006, a U.S. Food and Drug Administration (FDA) investigator inspected your manufacturing facility, Compressed Oxygen, USP, located at 1685 Gause Boulevard Suite 1246, Slidell, Louisiana. Medical gases, such as Compressed Oxygen, USP, are drug products as defined by 21 United States Code (USC) 321(g), Section 201(g) of the Federal Food, Drug, and Cosmetic Act (the Act). Our inspection found significant violations of the Current Good Manufacturing Practice (CGMP) regulations for drug products, set forth in Title 21, Code of Federal Regulations , (21 CFR), Parts 210 and 211. These violations cause your Compressed Oxygen, USP product to be adulterated within the meaning of 21 USC 3 51(a)(2)(B), Section 501(a)(2)(B) of the Act, as the methods used in, or the facilities or controls used for, the manufacturing, processing, packing, storage or holding of your product do not comply with CGMP regulations.
The CGMP violations include, but are not limited to, the following:
1. Failure to routinely calibrate, inspect, or check automatic, mechanical, or electronic equipment according to a written program designed to assure proper performance [21 CFR 211.68(a)]. Specifically, your cryogenic pumping system lacks qualification according to a written plan to assure all parts of the system, including the pump, power supply, electric components, vacuum hold and cryogenic jacket, will operate properly for their intended use every time [see Form 483 (483) Observation 1].
2. Failure to establish adequate written procedures for production and process control designed to assure drug products have the identity, strength, quality and purity they purport or are represented to possess [21 CFR 211.100(a)]. Specifically, your firm's "Quality Assurance Program" (QAP) manual, on page 108, allows for the use of "oil free" air, or ambient air applied by a squeeze bulb, to repressurize empty, returned cylinders in order to conduct the prefill odor test. Your firm has not demonstrated this procedure is equally effective at preventing the introduction of external contaminants into the cylinders as the FDA recommended procedure of using only medical grade gases for this purpose.
3. Failure to establish an adequate quality control unit having the responsibility and authority to approve or reject all drug products, and the authority to review production records to assure no errors have occurred or, if errors have occurred, they have been fully investigated, as required by 21 CFR 211.22(a). Specifically :
Review of batch production records for Oxygen USP by personnel with quality control unit authority failed to detect errors and omissions, constituting violations of 21 CFR 211.188, in the records for [redacted] lots out of [redacted] (483 Observations 3, 6c, 6d); and, [redacted]
Quality control unit personnel failed to perform an investigation into the failure of the filling equipment to fully pressurize the cylinders during a filling operation, in violation of 21 CFR 211.192.
4. Failure to maintain complete records of the periodic calibration of laboratory instruments required by 21 CFR 211.160(b)(4) and 211.194(d). Specifically, calibration records for the [redacted] oxygen analyzer on six Oxygen USP Packaging Control Records are incomplete (see 483 Observation 3).
5. Failure to assure each employee engaged in the manufacture, processing, and holding of a drug product has the education, training and experience required to perform their assigned duties [21 CFR 211.25(a)]. Specifically:
Personnel functioning as the quality control unit failed to review some batch records prior to release of the drug product as required by your firm's SOPs and failed to detect errors and omissions in [redacted] out of [redacted] batch records reviewed. These deficiencies and the failure of filling personnel to maintain CGMP required information as part of the batch record indicates a lack of understanding of regulatory requirements in this area (see 483 Observations 3 and 4); and, [redacted]
Personnel functioning as the quality control unit did not perform an investigation, as is required by 21 CFR 211.192, of the failure of the filling equipment to properly pressurize cylinders of Oxygen USP during a filling cycle observed (see 483 Observation 4).
The above violations are not intended to be an all-inclusive list, as other deficiencies may exist at your facility. It is your responsibility to assure your facility is operated in compliance with each requirement of the CGMP regulations and applicable statutes enforced by the FDA. Federal agencies are advised of the issuance of all warning letters about drugs so they may take this information into account when considering the award of contracts. Until FDA can confirm correction of the deficiencies observed during the most recent inspection, this office cannot recommend approval of any new applications listing this site as a manufacturer of drugs.
We recognize at the close of the inspection you made a verbal commitment to correct the observed deficiencies. Also, we acknowledge receipt of your firm's letters (one dated August 23, 2006 and second one undated, received September 11, 2006), written in response to the inspectional observations. While some of the stated corrective actions appear to be satisfactory, we find others to be inadequate. For example, your response to 483 Observation 1 states, "We shall validate the mobile pumping system" but provides no details, plans, or protocols . Although your corrective actions in response: to 483 Observations 3, 4, 6c and 6d appear to be adequate, they will have to be reviewed and verified during a future inspection of your firm.
You should take prompt action to correct all of the violations noted in this letter, and you should establish procedures whereby such violations do not recur. Failure to promptly correct violations may result in regulatory action without further notice such as seizure and/or injunction.
You should notify this office in writing, within fifteen (15) working days from your 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. You should include in your response documentation, such as qualification of the cryogenic pumping system, detailed information on specifics of your training program, review and approval of your QAP by qualified individuals, and corrected labels or other useful information to assist us in evaluating your corrections. If you cannot complete all corrections before you respond, you must explain the reason for your delay and state when you will correct any remaining deviations. Your responses will be reviewed and any corrective actions will be verified during our next inspection at your facility.
You can find guidance and information for the regulated industry regarding regulations for drug products through links at FDA's Internet home page website at http://www.fda.gov/oc/industry/.
Your reply should be directed to the U.S. Food and Drug Administration, Attention: Nicole F. Hardin, Compliance Officer, at the above address. If you have questions regarding any issue in this letter, please contact Ms. Hardin at (504) 219-8818, extension 102.
H. Ty Thornburg
New Orleans District