Inspections, Compliance, Enforcement, and Criminal Investigations
TYA Pharmaceuticals, Inc. Warning Letter Response
TERRY YON & ASSOCIATES, INC.
September 13, 2005
Mr. Jimmy E. Walthall
Director, Compliance Branch
Food and Drug Administration
555 Winderly Place, Suite 200
Maitland, FL 32751
Re: Response to Warning Letter FLA 02-56 (dated August 6, 2002)
Dear Mr. Walthall :
TYA Pharmaceuticals, Inc. immediately implemented the corrective actions described below in response to the above-referenced Warning Letter. Further, these corrective actions were acknowledged in the FDA report issued after its January 2004 follow-up inspection of the TYA facility.
1) TYA established and adheres to a complete procedures manual for CGMP compliance that encompasses all requirements set forth in 21 CFR, sections
210 & 211, as well as other CFR sections that govern repackaging of drags and drug products.
2) TYA packages drug products in unit dose strips utilizing packaging materials classified as USP Class A or Class B.
The firm previously adhered to FDA guidelines specifying a maximum expiration date of six months or 25 percent of the remaining time between the date of repackaging and the expiration date shown on the original manufacturer's bulk container (Section 430.100 (CPG 7132b.10A attachment B])
3) As of May 2005, upon consultation with FDA's Rockville, MD, office, TYA began placing a one-year expiration date on unit dose strips because the packaging materials are USP Class A.
Drug products repackaged in blister packs or "bingo" cards carry a six-month expiration date or 25 percent of the original manufacturer's expiration date, because the packaging materials are not USP Class A, but are USP Class B. (The proposed new guideline from FDA-Rockville specifies that Class A
material must be used for using a one-year expiration date.)
Our consultants notified FDA-Rockville that the packaging materials on the market for blister packs and bingo cards do not meet USP Class specifications . FDA indicated that it was unaware of this.
Section 480.200 (CPG 7132b.11) :
a) Written procedures have been followed and all major pieces of equipment have been qualified.
b) All major pieces of equipment bear ID tags indicating their status as CLEAN or NOT CLEAN.
c) Cleaning and maintenance logs are in use and documented as required by written procedures.
4) Cleaning procedures have been validated and an ongoing validation program is in effect.
5) CGMP training programs have been in place since the original inspection and prior to issuance of the Warning Letter. Peiser & Associates, Inc. conducted the most recent employee training session on August 18, 2005.
6) Recall procedures are in place and full documentation is being maintained.
7) TYA has in place a complete, up-to-date complaint procedure and maintains a complaint file. This file is periodically reviewed by both the firm's quality control and manufacturing directors, as well as by other TYA supervisory personnel as needed.
TYA Pharmaceuticals is committed to operating at all times in full compliance with FDA rules and regulations, consistent with its mission of providing quality, safe products to its customers.
2930 Crescent Drive
Tallahassee, FL 32301