Inspections, Compliance, Enforcement, and Criminal Investigations
Terry Yon & Associates, Inc ( dba TYA Pharmaceuticals) - Company Response 11/29/10
TERRY YON & ASSOCIATES, INC.
November 29, 2010
Mr. Winston R. Alejo
Compliance Officer, Florida District
U. S. Food and Drug Administration
555 Winderley Place, Suite 200
Maitland, Florida 32751
Re: Response to Warning Letter FLA-10-18 (dated May 12, 2010)
Dear Mr. Alejo:
Issuance of this Warning Letter indicates a fundamental conflict between FDA policy as contained in the Code of Federal Regulations and findings of the FDA’s Jacksonville field office.
Following the recommendation of the local FDA inspector, who has inspected our firm for years, TYA Pharmaceuticals requested that our FDA consultant conduct a thorough review of TYA’s operations with respect to constructing and maintaining a “clean room” for repackaging antibiotic pharmaceuticals. After the consultant and his associate made several visits to our facility and had extensive consultation with our staff, the consultant issued his recommendations – which were fully implemented by TYA.
Subsequently, the FDA dispatched two staff members from its Jacksonville office to review the measures we had taken in response to the consultant’s recommendations. One of these people was an investigator and the other was a “consumer safety officer” – neither of whom had ever visited our facility before. During the course of their inspection, they went outside several times to make telephone calls back to their office – presumably for guidance.
Contrary to provisions of the CFR stating that a “clean room” can be established within a repackaging facility, the report of the FDA’s Jacksonville representatives, in essence, requires TYA to construct a completely separate “clean room” outside and apart from its existing repackaging facility.
Following the inspection, TYA engaged (b)(4) to conduct “total organic compound” swab tests throughout our “clean room” as well as in various locations within the main repackaging area of our warehouse. Test results were at or below the established acceptable level: (b)(4) parts-per million.
In addition, TYA retained the (b)(4) firm to conduct a reverse air-flow test, using an (b)(4) unit, to measure differential pressure between the gowning and laminar air-flow rooms. (Incidentally, (b)(4) is the firm that does the testing for (b)(4) federally funded (b)(4). This test showed a negative airflow differential of (b)(4) – clearly below the required level. (b)(4) opinion was that the performance of the air handling system in our “clean room” actually exceeded the level necessary to prevent contaminating particles from escaping into the warehouse.
Further, as an extra precaution, TYA also packages under a laminar air-flow hood – which is not required under the Code of Federal Regulations. This hood, which is manufacturer-certified for sequential repackaging of several different drugs, has been widely used for many years in many “clean room” facilities throughout the country. All tests have proved that TYA’s “clean room” was in compliance.
TYA has spent $75,000-$100,000 in an attempt to comply with federal regulations, even though only a minimal amount of business was at stake for the firm. We did our best to meet the customer’s request for this service. It should be noted that our firm repackages like a community pharmacy, using finished products only – with no manufacturing using raw powder ingredients. We have never heard of a community pharmacy having an issue with antibiotics, even though they did not utilize a “clean room” or a hood to protect against possible cross-contamination.
In our opinion, the FDA’s requirement as issued by its Jacksonville representatives is in direct conflict with provisions of the Code of Federal Regulations. If FDA is going to require that a completely separate facility be constructed and maintained for repackaging antibiotic pharmaceuticals, then the CFR should be changed accordingly.
Terry Yon, President
2930 Crescent Drive
Tallahassee, FL 32301