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U.S. Department of Health and Human Services

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Enforcement Actions

Direct Dispensing, Inc. 02-Nov-06

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

Public Health Service
Food and Drug Administration

 

Florida District
555 Winderley Place
Suite 200
Maitland, Florida 32751
Telephone: 407-475-4731



CERTIFIED MAIL
RETURN RECEIPT REQUESTED

WARNING LETTER

FLA-07-02

November 2, 2006

Mr. Miguel Garcia Armengol
President
Direct Dispensing, Inc.
3123 NW 73rd Street
Miami, Florida 33487s

Dear Mr. Annengol:

The Food and Drug Administration (FDA) inspected your prescription (Rx) and over-the-counter (OTC) capsule and tablet repacking and relabeling facility at the above address on September 12-16, 2005, and on February 2-14 and March 28, 2006. During those inspections, Investigators Amber G. Wardwell and Jennifer M. Menendez obtained information, labeling, and records pertaining to the Rx and OTC drugs that you repackage and/or relabel. These materials disclosed significant misbranding violations under section 502 of the Federal Food, Drug, and Cosmetic Act (the Act) (21 U.S.C. § 352).

OTC Drug Products

FDA collected labeling for the following OTC products:S

  • "325 MG ACETAMINOPHEN . . . TAB . . . LOT: 11149 and 11725,"

  • "81 MG . . . ASPIRIN ENTERIC COATED . . . TAB . . . LOT: 11366,"

  • "325 MG . . . ASPIRIN-EC DELAYED-RELEASE ENTERIC COATED . . . TAB . . . LOT: 10064,"

  • "25 MG . . . DIPHENHYDRAMINE HCL . . . CAP . . . LOT: 10344,"

  • "DIPHENHYDRAMINE HCL 50 MG . . . CAP . . . LOT: 11372," and

  • "30 MG . . . PSEUDOEPHEDRINE HCL . . . TAB . . . LOT: 10784."

While the bottle labels for these OTC products use the terms "drug" and "medication", they bear no indications, directions, or warnings, except for the warning: "WARNING: KEEP THIS MEDICATION OUT OF THE REACH OF CHILDREN." In addition, as an example, Lot 11725 of the 325 mg Acetaminophen had only 371 labeling inserts for [redacted] bottles, and the bottle label for DIPHENHYDRAMINE HCL 50 MG . . . CAP . . . LOT : 11372" bears the statement : "USUAL DOSAGE: SEE PACKAGE INSERT." During the most recent inspection, Ms. Gabriel Guztrtan and Mr. Urbano Zamora of your firm confirmed that no additional labeling accompanied these products prior to their shipment to [redacted]. Based on the limited information regarding intended uses of these OTC products on the labeling and the lack of directions for use on the labeling, these products are misbranded under section 502( f)(1) of the Act (21 U.S.C. § 352(f)(1)). In addition, the products' labeling does not comply with the "Drug Facts" labeling requirements of 21 C.F.R. § 201.66, nor does it disclose the name of each inactive ingredient. Therefore, these products are further misbranded under sections 502(c) and 502(e)(1)(A)(iii), respectively,
of the Act (21 U.S.C. §§ 352(c) and 352(e)(1)(A)(iii)).

From records maintained by your firm, including invoices and batch records that identify trade names of leading brands with the same active ingredients, the Acetaminophen products are intended to be used as OTC internal analgesics and antipyretics. When offered for these uses, acetaminophen is covered by FDA's OTC Drug Review, though it is not yet subject to a final OTC drug monograph. See Tentative Final Monograph for Internal Analgesic, Antipyretic, and Antirheumatic Drug Products for Over-the- Counter Human Use, 53 Fed. Reg. 46204 (Nov. 16, 1988). These acetaminophen products are misbranded under section 502(f)(2) of the Act (21 U.S.C. § 352 (f)(2)) because they do not bear all of the warnings presently required for OTC acetaminophen-containing drug products. For example, there are no warnings about the use of this product with alcoholic beverages (21 C.F.R. § 201.322), or during pregnancy or when breast feeding (21 C.F.R. § 201 .63), or not to give to children under 3 years of age or use for more than 10 days unless directed by a doctor (21 C.F.R. § 369.21).

Additionally, based on records maintained by your firm, including invoices and batch records that identify trade names of leading brands with the same active ingredients, the Aspirin products are intended to be used as OTC internal analgesics. When offered for these uses, aspirin is covered by FDA's OTC Drug Review, though it is not yet subject to a final OTC drug monograph. See Tentative Final Monograph for Internal Analgesic, Antipyretic, and Antirheumatic Drug Products for Over-the-Counter Human Use, 53 Fed. Reg. 46204 (Nov. 16, 1988). The labeling for these products does not bear any of the warnings presently required for OTC aspirin-containing drug products. For example, there is no warning about the risks of Reye's Syndrome when using this product (21 C.F.R. § 201.314(h)), or warnings about the use of this product with alcoholic beverages (21 C.F.R. § 201.322), or during pregnancy or when breast feeding (21 C.F.R. § 201.63), or a warning regarding overdose (21 C.F.R. § 201.314(a)). Therefore, these products are misbranded under § 502(f)(2) of the Act (21 U.S.C. § 352(f)(2)).

Furthermore, based on records maintained by your firm, including invoices and batch records that identify trade names of leading brands with the same active ingredients, the dipenhydramine HCl products are intended to be used as OTC antihistamines. Diphenhydramine HC1 offered for this use is covered by FDA's OTC Drug Review and it must comply with the final monograph (FM) for OTC antihistamines (see 21 C.F.R. Part 341), or be the subject of an approved new drug application (NDA). These products are not the subject of an approved NDA. Therefore, these products are misbranded under section 502(f)(2) of the Act (21 U.S.C. § 352(f)(2)) because they do not bear any of the warnings presently required under the FM for OTC antihistamine-containing drug products. For example, there are no warnings for the following: that the use of the product may cause excitability, especially in children (21 C.F.R. § 341.72(c)(1)); that the product is not to be taken, unless directed by a doctor, by those with breathing problems, such as emphysema or chronic bronchitis, or by those with glaucoma or who have difficulty urinating due to an enlarged prostate (21 C.F.R. § 341.72(c)(2)); that the product may cause marked drowsiness, and its use with alcohol, sedatives, and tranquilizers may increase drowsiness, and to use caution when driving or operating machinery (21 C.F.R.§ 341.72(c)(4)); and that the product is not to be used with any other diphenhydramine-containing drug product (21 C.F.R. § 341.72(c)(7)).

Finally, from records maintained by your firm including invoices and batch records that identify trade names of leading brands with the same active ingredients along with an invoice issued by your firm, the psuedoephedrine HCl product is intended to be used as an OTC nasal decongestant. Pseudoephedrine HC1 offered for this use is covered by FDA's OTC Drug Review and it must comply with the FM for OTC nasal decongestants (see 21 C.F.R. Part 341), or be the subject of an approved NDA. This product is not the subject of an approved NDA. Therefore, this product is misbranded under section 502(t)(2) of the Act (21 U.S.C. § 352(f)(2)) because it does not bear any of the warnings presently required in the FM for OTC pseudoephedrine HC1-containing drug products. For example, there are no warnings for the following: not to exceed the recommended dosage, and to discontinue use and consult a doctor if nervousness, dizziness, or sleeplessness occurs (21 C.F.R. § 341.80(c)(1)(A)); to consult a doctor if symptoms do not improve within seven days or are accompanied by fever (21 C.F.R. § 341.80(c)(1)(B)); not to use by anyone with heart disease, high blood pressure, thyroid disease, diabetes, or with difficulty urinating due to an enlarged prostate, unless directed by a doctor (21 C.F.R. § 341.80(c)(1)(C)); and not to use if taking monoamine oxidase inhibitors (MAOI), or for two weeks after taking MAOI's (21 C.F.R.§ 341.80(c)(1)(D)).

Prescription Drug Products

During the February 2-14, 2006, inspection, FDA documented labeling deviations that cause at least some of your prescription drug products, as described below, to be misbranded. Section 502(f)(1) of the Act (21 U.S.C. § 352(f)(1)) requires that each drug have labeling that bears adequate directions for use unless exempted from this requirement by regulation. Directions for use are adequate only when they are sufficient to permit a layman to use the drug safely and for the purposes for which it is intended (21 C.F.R. § 201.5). Consequently, adequate directions for use cannot be written for prescription drug products, but under 21 C.F.R. § 201.100(c)(1) a prescription drug is exempt from the requirement of section 502(f)(1) if "labeling on or within the package from which the product is to be dispensed" provides adequate direction for use under which a practitioner licensed by law can use the drug safely and for the purposes for which it is intended.

As shown in the examples below, your firm's production records demonstrate that it is your practice not to include an adequate number of package inserts (one per each container of drug product) containing such directions in boxes of prescription products that your firm repackages and ships. The products identified below, and any other prescription drug products packaged without a corresponding insert, are misbranded.

(1) Production work order number 11683, dated November 17, 2005, for Clindamycin HC1 150 mg capsules, shows [redacted] bottles of 30 capsules each repackaged with only 4 inserts included with that box.
(2) Production work order number 11817, dated December 12, 2005, for Metformin HC1 500 mg tablets, shows [redacted] bottles of 30 tablets each repackaged with only 2 inserts included with that box.
(3) Production work order number 11985, dated January 16, 2006, for Doxycycline Hyclate 100 mg tablets, shows [redacted] bottles of 13 tablets each repackaged with only 31 inserts included with that box.
(4) Production work order number 11929, dated January 25, 2006, for Cephalexin HCI 500 mg capsules, shows [redacted] bottles of 40 capsules each repackaged with only 12 inserts included with that box.
(5) Production work order number 11939, dated January 10, 2006, for Erythromycin Stearate 250 mg tablets, shows [redacted] bottles of 40 tablets each being repackaged with only 30 inserts included with that box.
(6) Production work order number 11697, dated December 15, 2005, for Penicillin V Potassium 250 mg tablets, shows [redacted] bottles of 40 tablets each being repackaged with only 18 inserts included with that box.

We acknowledge receipt of your firm's responses dated October 5, 2005, and February 22, 2006, submitted by Mr. Lorie to this office. Those responses will be made part of the official file. We note, however, that despite your description in those letters of action on the part of your firm to resolve objectionable conditions noted during these inspections, we question your firm's commitment to effect the needed corrections. On numerous occasions in the past you have promised corrective action, but follow-up inspections by this office have revealed not only failures to effect the corrective action promised, but also the existence of new violative conditions. For example, in your October 5, 2005, response, this office was advised that "Drug Facts" inserts would be included with repackaged/relabeled OTC drug products. However, the most recent inspection disclosed that your firm continues to distribute OTC drugs without complete labeling and the labeling supplied with 371 bottles of "325 MG ACETAMINOPHEN . . . TAB . . . LOT: 11725" does not comply with the "Drug Facts" requirements in 21 C.F.R. § 201.66.

The violations described above are not meant to be all-inclusive. It is your responsibility to ensure that all drug products manufactured and distributed by your firm comply with the Act. Federal agencies are advised of the issuance of all Warning Letters pertaining to drugs and devices so that they may take this information into account when considering the award of contracts. We request that you take action immediately to correct these violations. Failure to do so may result in regulatory action without further notice, including seizure and/or injunction.

Please send a written response to this office within fifteen working days of receipt of this letter. Your response should describe the specific actions that you will take, or have taken, to correct the violations described in this letter. Your response should also include an explanation of each step being taken to prevent recurrence of similar violations. 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. Direct your response to the Food and Drug, Administration, Attention: Jimmy E. Walthall, Director, Compliance Branch, 555 Winderley Place, Suite 200, Maitland, FL 35271. If you have questions regarding any issue in this letter, please contact , Mr. Walthall at (407) 475-4734.

Sincerelv,

/S/

Emma R. Singleton
Director, Florida District