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U.S. Department of Health and Human Services

Inspections, Compliance, Enforcement, and Criminal Investigations

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Safeway Industries 27-Jul-06

Department of Health and Human Services' logoDepartment of Health and Human Services

Public Health Service
Food and Drug Administration

 


Minneapolis District Office
Central Region
212 Third Avenue South
Minneapolis, MN 55401
Telephone: (612)758-7132
FAX: (612) 334-4142



July 27, 2006

WARNING LETTER

Refer to MIN 06 – 30

CERTIFIED MAIL
RETURN RECEIPT REQUESTED

Scott M. Meinerz
President
Safeway Industries, Inc.
3372 N. Holton Street
Milwaukee, WI 53212-1652

Dear Mr. Meinerz:

The Food and Drug Administration (FDA) inspected your drug manufacturing facility located at 3372 N. Holton Street, Milwaukee, WI, on March 30 and 31, April 3-5, and June 1, 2006. The inspection verified that your firm manufactures and markets teat dips, teat sprays, and teat wipes for dairy cows. These teat dips, teat sprays, and teat wipes are identified as BioWay® COVERALL BARRIER TEAT DIP, BioWay® QAC TEAT DIP, BioWay® PREFERRED 1% CHLORHEXIDINE PRE & POST-MILKING TEAT DIP OR SPRAY, BioWay® & NON-STAINING CHG™ TEAT SPRAY, BioWay® CHG™ TEAT SPRAY BioWay® CHG™ TEAT DIP, SECURE IODINE TEAT DIP OR SPRAY [redacted] I-O-DINE, BioWay® IODIP™ Pre-Milking and Post-Milking Teat Dip, MAXI-DINE TEAT DIP, BIO-DINE 100 Pre-Milking and Post-Milking Teat Dip or Spray, BIO-DINE 110 Pre-Milking and Post-Milking Teat Dip or Spray, SUSTAIN™ Iodine Barrier Dip, BioWay-® BIO-FOAM 60 Pre-Milking and Post-Milking Foaming Teat Dip, BioWay® Bio-Dip™ Pre-Milking and Post-Milking Teat Dip or Spray, BIO-DINE 50 Pre-Milking and Post-Milking Teat Dip or Spray, BioWay®  BIO-DINE 25 Pre-Milking and Post-Milking Teat Dip or Spray, and 1-STEP PRE-MILKING TEAT WIPES.

The products listed above are labeled to aid in controlling organisms that may cause mastitis. The representations on the labeling for these products indicate that the products are intended for use in the prevention of disease in animals. The products are, therefore, drugs under section 201(g)(1) of the Federal Food, Drug, and Cosmetic Act (the Act) [21 U.S.C. 321{g)(1)]. The products are also new animal drugs under section 201(v) of the Act [21 U.S.C. 321(v)] because FDA is not aware of any evidence that they are generally recognized by qualified experts as safe and effective for their intended use.

None of the products listed above are covered by an approved new animal drug application. This causes the products to be unsafe within the meaning of section 512(a) of the Act [21 U.S.C. 360b(a)] and, thus, adulterated pursuant to section 501(a)(5) of the Act [21 U.S.C. 351(a)(5)].

In addition, our investigation found significant deviations from the current Good Manufacturing Practice (cGMP) for Finished Pharmaceuticals [Title 21, Code of Federal Regulations, Part 211 (21 CFR 211). Such deviations cause animal drug products manufactured at your facility to be adulterated within the meaning of Section 501(a)(2)(B) of the Act [21 U.S.C. 351(a)(2)(B)]. Our investigation found the following:

  1. The drug products do not bear an expiration date determined by appropriate stability data to assure they meet applicable standards of identity, strength, quality, and purity [21 CFR 211.137(a)].

  2.  There is no written testing program designed to assess the stability characteristics of the drug products [21 CFR 211.166(a)].

  3. Complaint records are deficient in that they do not include the findings of the follow-up [21 CFR 211.198(b)(2)].

  4. The responsibilities and procedures applicable to the quality control unit are not fully followed [21 CFR 211.22(d)].

  5. There is a lack of verification of component weight or addition [21 CFR 211.101(d)].

  6. Labels are not properly issued per the firm's procedures [21 CFR 21.1.125(f)].

  7. The batch production and control records do not include complete labeling control records, including specimens or copies of all labeling used [21 CFR 211.188(b)(8)].

  8. The batch records lack records of the cleaning for dedicated equipment [21 CFR 211.182].

  9. GMP training is not conducted on a continuing basis [21 CFR 211.25(a)].

 

Previously, on August 19, 2004, your firm was issued a Form FDA-483, Inspectional Observations (FDA-483) listing six deviations from cGMP, and on March 9, 2000, an FDA-483 isting 27 deviations from cGMP. On May 14, 1996, FDA issued a Warning Letter to your firm for multiple deviations of cGMP.

This letter is not intended to be an all-inclusive review of the products your firm manufactures and markets. It is your responsibility to ensure that your overall operation and the products you manufacture and market are in compliance with the Act.

You should take prompt action to correct these violations, and you should establish procedures whereby such violations do not recur. Failure to do so may result in regulatory action without further notice, including seizure and/or injunction. In addition, federal agencies are routinely advised of the issuance of Warning Letters so that they may take this Information into account when considering the award of  contracts.

Please notify this office in writing within fifteen (15) working days of receipt of this letter of the specific steps you have taken to correct the noted violations, Include an explanation of each step being taken to identify and to correct any underlying problems necessary to assure similar violations will not recur. You should include in your response copies of documents that support your corrective actions. If corrective action cannot be completed within fifteen (15) working days, state the reason for the delay and the time within which the corrections will be completed.

Your reply should be sent to Brian D. Garthwaite, Ph.D., Compliance Officer, Food and Drug Administration, Minneapolis District Office, 212 Third Avenue South, Minneapolis, Minnesota 55401.

Sincerely,

/s/

W. Charles Becoat
Director
Minneapolis District