Recsei Laboratories, LLC 1/15/14
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Department of Health and Human Services
|Public Health Service|
Food and Drug Administration
Los Angeles District
Irvine, CA 92612-2506
VIA UNITED PARCEL SERVICE
January 15, 2014
WL # 09-14
Paul A. Recsei, Partner
Recsei Laboratories, LLC
330 S. Kellogg Avenue, Suites L & M
Goleta, California 93117
Dear Mr. Recsei:
The U.S. Food and Drug Administration (FDA) conducted an inspection on July 1-2, 2013 of your pharmaceutical manufacturing facility, Recsei Laboratories, LLC, located at 330 S. Kellogg Avenue, Suites L/M, Goleta, California.
Unapproved New Drugs
Based on information collected during the recent inspection, you manufacture and distribute unapproved new drugs in violation of sections 301(d) and 505(a) of the Act [21 U.S.C. §§ 331(d) and 355(a)]. Furthermore, by introducing misbranded drugs into interstate commerce, you are in violation of section 301(a) of the Act [21 U.S.C. § 331(a)].
The unapproved prescription drugs include, but are not limited to:
As labeled, the above products are drugs within the meaning of section 201(g)(1)(B) and (C) of the Act [21 U.S.C. §§ 321(g)(1)(B) and (C)] because they are intended for use in the diagnosis, cure, mitigation, treatment, or prevention of disease and because they are intended to affect the structure or function of the body. Further, these drugs, as marketed by your firm, are "new drugs" within the meaning of section 201(p) of the Act [21 U.S.C. § 321(p)] because they are not generally recognized as safe and effective for their labeled uses. Under sections 301(d) and 505(a) of the Act [21 U.S.C. §§ 331(d) and 355(a)], a new drug may not be introduced into or delivered for introduction into interstate commerce unless an application approved by FDA under either section 505(b) or (j) of the Act [21 U.S.C. § 355(b) or (j)] is in effect for the drug. Based upon our information, there are no FDA-approved applications on file for the above drugs. The marketing of these drugs, or other applicable drugs, without approved applications constitutes a violation of these provisions of the Act.
Because the above drugs are intended for conditions that are not amenable to self-diagnosis and treatment by individuals who are not medical practitioners, adequate directions cannot be written for them so that a layman can use them safely for their intended uses. Consequently, their labeling fails to bear adequate directions for their intended uses, causing them to be misbranded under section 502(f)(l) of the Act [21 U.S.C. § 352(f)(1)]. Because your drugs lack a required approved application, they are not exempt under 21 C.F.R. § 201.115 from the requirements of section 502(f)(1) of the Act. The introduction or delivery for introduction into interstate commerce of these drugs therefore violates sections 301(a) of the Act [21 U.S.C. § 331(a)].
Over the Counter (OTC) Drugs
We also note that labeling was obtained for your over-the-counter (OTC) external analgesic drug product, (b)(4). According to its label, this product is intended for use as an anti-itch and topical analgesic drug product. Such indications are being addressed under the Tentative Final Monograph (TFM) for OTC External Analgesic Drug Products dated February 8, 1983 (48 Fed. Reg. 5852) and the TFM for External Analgesic Poison Ivy, Poison Oak, Poison Sumac, and Insect Bites Drug Products dated October 3, 1989 (54 Fed. Reg. 40818). However, while both of (b)(4) active ingredients are individually discussed in the proposed rule, the rulemaking does not propose or otherwise discuss combining hydrocortisone with any other active ingredient including diphenhydramine hydrochloride. Furthermore, diphenhydramine hydrochloride is only proposed at a concentration of 1 to 2 percent and not at (b)(4) as found in (b)(4). We are not aware of a product with such a formulation and labeling as (b)(4) being otherwise eligible for inclusion in the OTC Drug Review nor are we aware of such a product being generally recognized as safe and effective. Should you have evidence of your product or a similarly formulated and labeled product being eligible for inclusion in the OTC Drug Review we welcome you to submit such information. Absent such information, (b)(4) would be an unapproved “new drug” subject to regulatory action.
The violations cited in this letter are not intended to be an all-inclusive statement of violations that exist at your facility in connection with your product(s). You are responsible for investigating and determining the causes of the violations identified above and for preventing their recurrence or the occurrence of other violations. It is your responsibility to assure that your firm complies with all requirements of federal law and FDA regulations.
You should take prompt action to correct the violations cited in this letter. Failure to promptly correct these violations may result in legal action without further notice, including, without limitation, seizure and injunction. Other federal agencies may take this Warning Letter into account when considering the award of contracts.
If, as a result of receiving this Warning Letter or in general, you are considering making a decision that will result in a decreased number of finished drug products or active pharmaceutical ingredients produced by your manufacturing facility, FDA requests that you contact CDER’s Drug Shortages Program immediately, as you begin your internal discussions, at firstname.lastname@example.org
in order to ensure that your action(s) does not adversely affect the public health.
During the inspection, our investigator also observed deviations from current good manufacturing practice (CGMP) regulations in the manufacture of drug products at your facility. As a manufacturer of human drugs it is your responsibility to assure that any drug products produced, now or in the future, are manufactured in conformance with CGMP as delineated in 21 CFR parts 210 and 211.
For example, your firm has not established the reliability of your component suppliers analyses through appropriate validation of the suppliers test results at regular intervals as required by 21 CFR § 211.84(d)(2). In addition, components are not reexamined or retested to show continued suitability after being kept in storage for long periods of time or exposure to conditions that may adversely affect the components, as required by 21 CFR § 211.87. Also, your products fail to bear expiration dates determined by appropriate stability data, as required by 21 CFR § 211.137 because your firm failed to establish and follow an adequate written testing program designed to assess the stability characteristics of drug products as required by 21 CFR § 211.166(a). Finally, your firm failed to establish and follow adequate written procedures for the cleaning and maintenance of equipment, as required by 21 CFR § 211.67(b) in that you have not established the effectiveness of the cleaning agents used.
We acknowledge the verbal commitments made to our investigators during the inspection to implement corrective actions in response to the CGMP deviations found. However, these commitments were lacking in detail and FDA has not received any documentation from your firm to indicate implementation of corrective actions or provide timeframes for their implementation. Please provide documentation, including any revised procedures or examples of the results from any additional testing initiated since the inspection, in your response to this letter.
Due to the occurrence of repeat cGMP issues at your firm, we recommend that you engage a third party consultant with appropriate cGMP expertise to assess your firm’s facilities, procedures, processes and systems, to ensure that the drugs you manufacture have their identity, strength, quality and purity.
Within fifteen (15) working days of receipt of this letter, please notify this office in writing of the specific steps that you have taken to correct 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 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 (b)(4), (b)(4) and (b)(4), your response should so indicate, including the reasons that, and the date on which, you ceased production. Also, please indicate your progress in updating the drug listing files in accordance with 21 CFR 207.30(a)(2).
Your response should be sent to:
Mr. Blake Bevill
Director, Compliance Branch
U.S. Food & Drug Administration
Irvine, CA 92618
If you have any questions about the content of this letter please contact: Ms. Mariza M. Jafary, Compliance Officer, at (949) 608-2977.
Steven E. Porter, Acting Director
Los Angeles District
Hugo Cornejo, Acting Chief
California Department of Public Health
Food and Drug Branch
1500 Capitol Avenue MS 7602
PO Box 997435
Sacramento, CA 95899-7435
Attn: FDA Correspondence