Department of Health and Human Services' logo Department of Health and Human Services

Public Health Service
Food and Drug Administration
Florida District Office

 

555 Winderley Pl #200
Maitland, FL 32751
Telephone: 407-476-4700
FAX: 407-476-4769

June 25, 1998
WARNING LETTER
VIA CERTIFIED MAIL, RETURN RECEIPT REQUESTED

Brett J. Phillips, President
Phillips Gulf Corp.
8767 115th Ave N
Largo, FL 33773

Ref. No. FLA-98-58

Dear Mr Phillips:

During an inspection of your facility located in Largo, FL, on December 9, 1997 to January 15, 1998, FDA Investigator Paul 1. Figerole determined that you distribute Arth-Rx with Neurocaine topical lotion, which is labeled for conditions which cause it to be considered a drug within the meaning of Section 201 (g) of the Federal Food, Drug, and Cosmetic Act (the Act).

The above-stated inspection revealed that the drugs you distribute are adulterated within the meaning of Section 501(a)(2)(B) of the Act, as follows:

  1. Failure to adequately investigate 22 injury complaints received concerning Arth-Rx.
  2. Failure to properly segregate recalled products from products held for sale.
  3. Failure to have or assure there are written procedures for:
    • Handling of complaints;
    • Handling of recalled or returned product;
    • Warehousing and distribution of drug products; and,
    • Approval or rejection of drug products manufactured for your firm by another company, including identification of the person or persons responsible for such approval or rejection.

In addition, two lots of Arth-Rx are also adulterated within the meaning of section 501(c) in that they have been shown by FDA analysis to contain 130-150% of the declared capsaicin.

This letter is not intended to be an all-inclusive list of deficiencies at your facility. It is your responsibility to ensure adherence to each requirement of the Act and regulations. Please refer to the Form FDA 483, which was left with you by the investigator at the close of the inspection.

You should take prompt action to correct these violations. Failure to promptly correct these violations may result in regulatory action being initiated by the Food and Drug Administration without further notice. These actions include, but are not limited to seizure, injunction, and/or civil penalties.

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 these violations and to prevent the recurrence of similar violations. Please include in your response your intentions regarding the two lots found by analysis to be superpotent. If corrective action cannot be completed within fifteen working days, state the reason for the delay and the time within which corrections will be completed.

Your response should be sent to the Food and Drug Administration, Orlando District Office, 555 Winderley Pl, Maitland, FL 32751, Attention: Martin E. Katz, Compliance Officer.

Sincerely,
/s/
Douglas D. Tolen District Director

This page was posted on August 20, 2006.

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