| Public Health Service Food and Drug Administration |
Los Angeles District |
Department of Health and Human ServicesWarning Letter
CERTIFIED MAIL
RETURN RECEIPT REQUESTED
October 17, 2011
W/L 03-12
Marilyn Taxon-Donsbach
President/Owner
Health Advances USA, Inc.
696 Naples Street
Chula Vista, California 91911-1635
Dear Ms. Taxon-Donsbach:
The United States Food and Drug Administration (FDA) conducted an inspection of Health Advances USA, Inc. located at 696 Naples Street, Chula Vista, California on May 16, 2011 to May 24, 2011. We determined that the inspection revealed serious violations of FDA’s Current Good Manufacturing Practice (CGMP) regulations for dietary supplements, under Title 21, Code of Federal Regulations (CFR), Part 111 (21 CFR Part 111). These violations cause the dietary supplement products you manufacturer to be adulterated within the meaning of section 402(g)(1) of the Act [21 U.S.C. § 342(g)(1)] in that these products have been prepared, packed, or held under conditions that do not meet CGMP requirements for dietary supplements. You manufacture several products labeled as dietary supplements, such as Pentrexcilina Citricilina, Duro Neuro Extra Forte, Angin, Angin Xtra Forte, Delgadex, Desin-Flanex 850, Super Sleeper, Super Complejo B, Colesstol 200, Delgadex, Radiaxina, and M-Stane.
We have received your response, dated June 14, 2011, concerning our investigator’s observations noted on the Form FDA 483, List of Observations that was issued to you on May 24, 2011. Your responses are inadequate in addressing the violations. Specifically, you provided no supporting documentation as evidence that they were corrected. The significant violations documented during the inspection include the following:
1. You failed to establish written procedures for manufacturing operations, as required by 21 CFR 111.353 and to make and keep records of these written procedures, as required by 21 CFR 111.375. The requirements for manufacturing operations are specified in 21 CFR 111.355, 111.360, 111.365, and 111.370.
2. Your batch production records (BPR) did not include complete information relating to the production and control of each batch and the requirements to be included in a batch record, as required by 21 CFR 111.255(b) and 111.260. For example, your BPR for the Angin Original Flavor, Lot #10272 did not include the following required information:
A. The identity of the equipment and processing lines used in producing the batch [21 CFR 111.260(b)].
B. A statement of the actual yield and percentage of theoretical yield at appropriate phases of processing [21 CFR 111.260(f)].
C. Documentation of the manufacture of the batch at the time of performance [21 CFR 111.260(j)(2)]. Specifically, the following information was not documented in your BPR at the time of performance:
i. The initials of the person responsible for verifying the weight or measure of each component used in the batch [21 CFR 111.260(j)(2)(ii)].
ii. The initials of the person responsible for adding the component used in the batch [21 CFR 111.260(j)(2)(iii)].
D. Documentation at the time of performance of packaging and labeling operations [21 CFR 111.260(k)].
E. Documentation at the time of performance that quality control personnel approved and released, or rejected, the batch for distribution [21 CFR 111.260(l)(3)].
3. You failed to establish in-process specifications for any point, step, or stage in the Master Manufacturing Record (MMR) where control is necessary to help ensure that specifications are met for the identity, purity, strength and composition of the dietary supplements and, as necessary, for limits on those types of contamination that may adulterate or may lead to adulteration of the finished batch of the dietary supplements, as required by 21 CFR 111.70(c)(1). For example, you did not include blend time and speed specifications for the in-process production of Angin Original Flavor tablets (lot # (b)(4)) and Dolo Neuro capsules (lot # (b)(4)).
4. You failed to establish specifications for the packaging and labeling of the finished packaged and labeled dietary supplements, as required by 21 CFR 111.70(g).
5. Quality control personnel must approve or reject all processes, written procedures, controls, tests and examinations, and deviations from or modifications to them, that may affect the identity, purity, strength, or composition of a dietary supplement, as required by 21 CFR 111.105(a). Specifically, your quality control personnel failed to approve the following written procedures: Procedure on Handling Out-of-Specification Results and Procedure in the Handling, Storage, and Inspection of Incoming Raw Materials and Components.
6. You failed to quarantine packaging and labels before you use them in the manufacture of a dietary supplement until you complete certain steps, as required by 21 CFR 111.160(c). Specifically, you indicated to our investigator that you have no controls in place for the labels you receive from your customers and that quality control does not approve or release the labels prior to use.
7. Your firm failed to establish sampling plans for obtaining representative samples as required by 21 CFR 111.315(b). Specifically, you indicated to our investigator that you have not established any sampling plans.
8. You failed to store cleaned and sanitized portable equipment and utensils that have contact surfaces in a location and manner that protects them from contamination, as required by 21 CFR 111.27(d)(7). Specifically, our investigator observed cleaned and sanitized pails and large containers stored directly on the floor in your facility where it could become contaminated.
9. You failed to meet the sanitation requirements under 21 CFR 111.15(c) for cleaning compounds, sanitizing agents, pesticides, and other toxic materials. For example,
A. You must not hold toxic materials in a physical plant in which components, dietary supplements, or contact surfaces are manufactured or exposed, unless those materials are necessary to maintain clean and sanitary conditions, for use in laboratory testing procedures, for maintaining or operating the physical plant or equipment, or for use in the plant’s operations [21 CFR 111.15(c)(2)]. However, our investigator observed you held in your facility toxic materials such as graffiti remover, turpentine, and paints.
B. You did not identify and hold cleaning compounds, sanitizing agents, pesticides, pesticide chemicals, and other toxic materials in a manner that protects against contamination of components, dietary supplements, or contact surfaces [21 CFR 111.15(c)(3)]. Specifically, our investigator observed you had unidentified bottles of liquids and pails on a shelf and stainless steel table in your facility.
The above violations are not meant to be an all-inclusive list of the violations that exist in connection with your products and their labeling. You are responsible for ensuring that all of your products are in compliance with the Act and FDA regulations. Failure to promptly correct the violations specified above may result in enforcement action without further notice. Such enforcement action may include seizure of illegal products and/or injunctions against manufacturers and distributors of illegal products [21 U.S.C. §§ 334 and 332].
Your response dated June 14, 2011 indicates your firm will no longer manufacture the following products: Dolo Neuro, Foot Hongo, Sedal Forte & Sana Antifungal Spray, but plan on establishing written procedures, master production, and control records for “nutraceuticals” products. Please explain what you mean by the term “nutraceutical” products and the name of the specific products to which you are referring. In addition, please let us know if you plan to continue to manufacture the following products: Sulfa Peni and Chiro-Assist.
Concerning observation 25 in the FDA-483 and your response to it, we will verify the adequacy of it during our next inspection.
Please respond in writing within fifteen (15) working days from your receipt of this letter. Your response should outline the specific actions you are taking to correct these violations and to prevent similar violations from occurring in the future. If you cannot complete all corrections before you respond, you should explain the reason for your delay and state when you will correct any remaining violations.
Your reply should be sent to the following address: Food and Drug Administration, Attention: Blake Bevill, Director Compliance Branch, 19701 Fairchild, Irvine, California 92612-2445. If you have any questions regarding this letter, contact Mr. Blake Bevill at 949-608-4426.
Sincerely,
/s/
Alonza E. Cruse
District Director
Los Angeles District
No comments:
Post a Comment