Inspections, Compliance, Enforcement, and Criminal Investigations
Jer-Vic Inc., dba Foy's Pigeon Supplies 14-May-08
Department of Health and Human Services
Public Health Service
RETURN RECEIPT REOUESTED
May 14, 2008
Mr. Gerald E. Gagne, Owner
Jer-Vic Inc., dba Foy's Pigeon Supplies
3185 Bennett's Run Road
Beaver Falls, Pennsylvania 15010-5270
Dear Mr. Gagne:
An inspection of your facility, Jer-Vic Inc., dba Foy's Pigeon Supplies, located at 3185 Bennett's Run Road, Beaver Falls, Pennsylvania, was conducted by a Food and Drug Administration (FDA) investigator on January 29 and 31, 2008. During the inspection, our investigator documented serious violations of the Federal Food, Drug, and Cosmetic Act (the Act). Drugs that are repackaged, relabeled, and distributed by your firm are unsafe under section 512(a) of the Act [21 U.S.C. § 360b(a)], and adulterated within the meaning of sections 501(a)(5) and 501(a)(2)(B) of the Act [21 U.S.C. § 351(a)(5) and 21 U.S.C. § 351(a)(2)(b)], and misbranded within the meaning of section 502(o) of the Act [21 U.S.C. § 352(o)].
The inspection verified that your firm repackaged, relabeled, and distributed the new animal drug Foy's Baytril Liquid. Foys's Baytril Liquid is a drug within the meaning of section 201(g)(1)(B) of the Act [21 U.S.C. § 321(g)(1)(B)] because it is intended for use in the diagnosis, cure, mitigation, treatment, or prevention of disease. In addition, Foy's Baytril Liquid is a new animal drug. Section 201(v) [21 U.S.C. 321(v)] of the Federal Food, Drug, and Cosmetic Act defines "new animal drug" in part, as a drug which is not generally recognized, among experts qualified by scientific training and experience to evaluate the safety and effectiveness of animal drugs, as safe and effective for use under the conditions prescribed, recommended, or suggested in the labeling.
New animal drugs may not be legally marketed in the absence of an approved New Animal Drug Application (NADA).
Foy's Baytril Liquid is adulterated under section 501(a)(5) of the Act [21 U.S.C. § 351(a)(5) because it is unsafe within the meaning of section 512(a) of the Act [21 U.S.C.§ 360b(a)]. Under section 512(a) of the Act [21 U.S.C. § 360b(a)], a new animal drug is deemed to be unsafe unless an approved New Animal Drug Application (NADA) is in effect for the specific product in question.
The inspection also revealed significant deviations from current Good Manufacturing Practice regulations (cGMP), Title 21, Code of Federal Regulations, Parts 210 and 211(21 C.F.R. Parts 210 and 211). These cGMP deviations cause your drug product to be adulterated within the meaning of section 501(a)(2)(B) of the Act [21 U.S.C. § 351(a)(2)(B)], in that the test methods used in, and procedures and controls used for, the manufacture, processing, packing, and holding of drugs do not conform with cGMP regulations to assure that such drugs meet the requirements of the Act as to safety, and have the identity and strength, and meet the quality and purity characteristics, which they purport or are represented to possess. Our investigator found several significant deviations from the cGMPs regulations, including but not limited to:
° Failure to verify the identity of each component of a drug product as required by 21 C.F.R. § 211.84(d)(1). Specifically, the incoming components, including Enrofloxacin are not tested to verify the identity prior to repackaging.
° Failure to test each component for conformity with all appropriate written specifications for purity, strength, and quality as required by 21 C.F.R. § 211.84(d)(2). Specifically, the incoming components, including Baytril (enrofloxacin), are not tested for purity, strength, and quality prior to repackaging.
°Failure to establish separate or defined areas or other control systems of adequate size to prevent contamination or mix-ups. The firm does not have a dedicated area for the repackaging operations and procedures as required by 21 C.F.R. § 211.42(c).
Further, all drugs you prepare are misbranded within the meaning of section 502(o) of the Act [21 U.S.C. § 352(o)] because you have not registered your establishment under section 510 of the Act [21 U.S.C. § 360], and the drug products have not been listed as required under section 510(j) of the Act [21 U.S.C. § 360(j)].
The issues and violations cited in this letter are not intended to be an all-inclusive list of violations that exist at your facility. You are responsible for investigating and determining the causes of the violations identified above and for preventing their recurrence and the occurrence of other violations. It is your responsibility to ensure that your overall operation and the products you manufacture, repackage, and distribute are in compliance with all requirements of federal law and FDA regulations. For example, you are required to comply with all applicable current Good Manufacturing Practice regulations. Further, all products you sell must be subject to an approved New Animal Drug Application.
You should take prompt action to correct the violations cited in this letter. Failure to promptly correct these violations may result in FDA initiating legal action without further notice, including but not limited to seizure and injunction.
Within fifteen (I5) working days of receipt of this letter, please notify this office in writing of the specific steps that you have taken to correct the violations. Include an explanation of each step being taken to prevent the recurrence of violations, as well as copies of related documentation. If you cannot complete corrective action within fifteen (15) working days, state the reason for the delay and the time within which you will complete the correction. If you no longer manufacture or market any of your drug products, your response should so indicate, including the reasons for, and the date on which, you ceased production.
Your reply should be directed to the Food and Drug Administration, Attention: Robin M. Rivers, Compliance Officer, at the address noted in the letterhead.
Thomas D. Gardine
Philadelphia District Office