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U.S. Department of Health and Human Services

Inspections, Compliance, Enforcement, and Criminal Investigations

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Home Health Pavilion, Inc 29-May-03

Department of Health and Human Services' logoDepartment of Health and Human Services Public Health Service
Food and Drug Administration
  New York District
158-15 Liberty Avenue
Jamaica, NY 11433


May 29, 2003


REF: NYK-2003-27

Mr. Asrar Ahmed
Home Health Pavilion, Inc.
5027 Route 9W North
Newburgh, NY 12550

Dear Mr. Ahmed:

An inspection of your medical oxygen manufacturing firm was conducted on March 17, 18 and 19, 2003 by Investigator Richard K. Glabach. At the conclusion of the inspection, a Form FDA 483, List of Inspectional Observations (copy attached) was issued to you.

From our evaluation of Form FDA 483, the inspection report, and the documents submitted with that report, we conclude that the Oxygen USP sold by your firm is misbranded within the meaning of Section 502(c), 503(b), 502(b), and 502(o) of the Federal Food, Drug, and Cosmetic Act (the Act), and it is adulterated within the meaning of Section 501(a)(2)(B) of the Act.

Specific misbranding violations include:

(1.) The cylinders of Oxygen USP are misbranded because they lack any name of the product as required by Section 502(c) of the Act and 21 CFR 201.50(a). Inspection revealed [redacted] of [redacted] cylinders refilled by your firm and held for distribution failed to bear the required Oxygen USP label. Your firm had no labels in stock for labeling cylinders received without this required labeling which were subsequently filled by your firm.

(2.) The above cylinders of compressed Oxygen USP are misbranded because they are not safe for use except under the supervision of a practitioner licensed by law to administer the drug yet fail to bear an "Rx only" legend as required by 503 (b)(4)(A) of the Act and 21 CFR201.100(b).

(3.) The above cylinders of Oxygen USP are misbranded because their labeling fails to contain a statement of quantity of contents as required by Section 502(b)(2) of the Act and 21 CFR 201.51.

(4.) The cylinders of Oxygen USP are misbranded because their labeling fails to adequately identify the place of business of the manufacturer, packer, or distributor as required by Section 502(b)(1) of the Act and 21 CFR 201.1(i). Although your firm applies a label providing the name, state, telephone number and lot number, this label does not include the city and zip code.

(5.) Further, the cylinders are misbranded within the meaning of section 502(o) in that they were manufactured in an establishment not duly registered under section 510(b) of the Act and the drug has not been listed as required by section 510(j) of the Act and 21 CFR 207.20(a). The most recent registration documentation your firm could produce is dated March 21, 1997.

Specific adulteration violations include:

(1.) Failure to perform an odor test for every finished batch of Oxygen USP, prior to release for distribution, as required by the USP (21 CFR 211.165(a)).

(2.) Failure to establish written procedures specifying the responsibilities and procedures applicable to the quality control unit as required by 21 CFR 211.22(d).

(3.) Failure to establish adequate written procedures for production and process control designed to assure that the drug product has the identity, strength, quality, and purity it purports to possess as required by 21 CFR 211.100(a).

For example, current written procedures do not assure proper filling and testing of cylinders of Oxygen USP in that they do not require complete testing for valve assembly leaks or testing for heat of compression.

In addition, there is no documentation to show that written procedures posted for Oxygen USP filling have been drafted by an appropriate organizational unit or reviewed and approved by a quality control unit.

(4.) Failure to document that each significant step in the manufacture of the drug product has been carried out as required by 21 CFR 211.188(b) in that the batch records for Oxygen USP do not document open valve leak checks, finished product cylinder temperature, odor test results, or actual product purity results.

(5.) Failure to provide employee training on a continuing basis to assure their knowledge and understanding of the drug cGMP regulations as they relate to their assigned functions as required by 21 CFR 211.25. Staff interviewed during the inspection were not familiar with current good manufacturing practice regulations for drugs.

(6.) Drug product production and control records are not reviewed and approved by a quality control unit to determine compliance with established, approved written procedures before a batch is released or distributed in accordance with 21 CFR 211.192 in that the production and control records reviewed at your firm showed no documentation of review and approval by a quality control unit or individual.

(7.) Failure to establish and implement written procedures covering the receipt, identification, storage, handling, examination, reconciliation, issuance, return and security of all labeling (21 CFR 211.122, 211.125 and 211.130).

Your firm has no procedures covering the above-mentioned operations. Such procedures are intended in part to prevent the types of misbranding violations observed onsite during the inspection.

(8.) Failure to formulate batches with the intent to provide 100 percent of the labeled or established amount of active ingredient as required by 21 CFR 211.101(a) in that your firm routinely overfills cylinders to 2200 PSI. Further, some of the cylinders used are labeled with tables specifying flow rates and pressures. The highest pressure noted on these tables was 2000 PSI. There is no assurance that the practice of overfilling cylinders does not compromise the structural integrity of the cylinder.

(9.) Failure to assure that drug product containers are clean as required by 21 CFR 211.94(c) in that the vacuum pump used to evacuate gas from each cylinder before filling is only capable of pulling a vacuum of 22 inches of mercury. There is no assurance that this vacuum is adequate to evacuate cylinders of any residual gas.

(10.) Failure to conduct periodic calibration of digital thermometers, vacuum/pressure gauges and pigtail check valves in accordance with 21 CFR 211.68(a). Further, your firm does not have a written program designed to assure proper performance of such equipment.

(11.) Failure to establish written procedures describing the handling or all written and oral complaints regarding a drug product and including provision for review by the quality control unit, of any complaint involving the possible failure of a drug product to meet any of its specifications and, for such drug products, a determination as to the need for an investigation as required by 21 CFR 211.198(a). The "Patient Communication Form" established for recording complaints does not include a provision of quality control unit review.

(12.) Failure to establish written procedures for cleaning and maintenance of equipment as required by 21 CFR 211.67.

Neither the above identification of cGMP violations nor the inspectional observations (Form FDA 483) presented to you at the conclusion of the inspection is intended to be an all-inclusive list of deficiencies at your facility. It is your responsibility to ensure adherence with each requirement of the Act and its implementing regulations. Federal agencies are advised of the issuance of all warning letters about drug products so that they may take this information into account when considering the award of contracts.

You should take prompt action to correct these deviations. Failure to promptly correct these deviations may result in regulatory action without further notice. Such regulatory action may include seizure and/or injunction.

Your firm must also take prompt action to register with the agency as a drug manufacturer and to file a drug listing form for the Oxygen USP. For information about how to register your manufacturing facility and list your drug product please visit the agency's web site at www.fda.gov/cder/drls/ or call the Center for Drug Evaluation and Research's Product Information Management Branch at 301-594-1086.

We acknowledge the corrective actions outlined in your April 14, 2003 response with respect to obtaining proper labels for your cylinders of Oxygen USP. However, most of the violations listed above have yet to be fully addressed.

You should notify this office in writing, within 15 working days of receipt of this letter, of (1) each step that has been or will be taken to completely correct the current violations and to prevent the recurrence of similar violations; (2) the time within which the corrections will be completed; (3) any reason why the corrective action has not been completed within the response time; and (4) any documentation necessary to show the corrections have been achieved.

Your reply should be sent to the attention of Lillian C. Aveta, Compliance Officer, Food and Drug Administration, 158-15 Liberty Avenue, Jamaica, New York 11433, Tel. (718) 662-5576.



Jerome G. Woyshner
District Director