| Public Health Service Food and Drug Administration |
| Los Angeles District Pacific Region 19701 Fairchild Irvine, CA 92612-2506 Telephone: 949-608-2900 FAX: 949-608-4415 |
Department of Health and Human ServicesWARNING LETTER
CERTIFIED MAIL
RETURN RECEIPT REQUESTED
August 23, 2010
W/L 41-10
Gina M. Stack
President/CEO
IriSys, Inc.
8810 Rehco Rd., Suite F
San Diego, CA 92121-3262
Dear Ms. Stack:
During our March 16 through April 01, 2010 inspection of your pharmaceutical manufacturing facility, IriSys, Inc., located at 8810 Rehco Rd., Suite F, San Diego, California, investigator(s) from the Food and Drug Administration (FDA) identified significant violations of Current Good Manufacturing Practice (CGMP) regulations for Finished Pharmaceuticals, Title 21, Code of Federal Regulations, Parts 210 and 211. These CGMP violations cause your drug product(s) to be adulterated within the meaning of section 501(a)(2)(B) of the Federal Food, Drug, and Cosmetic Act (the Act) [21 U.S.C. § 351(a)(2)(B)] in that the methods used in, or the facilities or controls used for, their manufacture, processing, packing, or holding do not conform to, or are not operated or administered in conformity with, CGMP.
In addition, your prescription drugs are manufactured without an approved application. As described below, these drugs are unapproved new drugs and by introducing them into interstate commerce, you are in violation of sections 301(d) and 505(a) of the Act [21 U.S.C. §§ 331(d) and 355(a)]. These unapproved new drugs are also misbranded pursuant to section 502(f)(1) of the Act [21 U.S.C. § 352(f)(1)], and by introducing them into interstate commerce you are in violation of section 301(a) of the Act [21 U.S.C. § 331(a)].
We have reviewed your firm's responses of April 15, 2010, May 14, 2010 and June 15, 2010, and note that all responses lack sufficient collective actions.
Specific violations observed during the inspection include, but are not limited to, the following:
CGMP Violations
1. Your film does not have adequate written procedures for production and process controls designed to assure that the drug products you manufacture have the identity, strength, quality, and/or purity they purport or are represented to possess [21 C.FR § 211.100(a)].
For example, during the process qualification stage of the process validation for Donnatal Elixir, you made equipment and process modifications without adequate change control. These modifications include adjusting mixing times, (b)(4), and changing the order in which you add raw materials. Because you made these changes without adequate written procedures, your manufacturing process could not be confirmed as being capable of routine commercial manufacturing, which can deliver a product that meets its critical quality attributes.
Your response is inadequate in that your film's strategy during process validation was concurrent release of batches. We expect rare use of concurrent release of batches, but if you choose to release batches concurrently, you should make conclusions about the manufacturing process only after the protocol is completed and you have fully evaluated your data.
2. Your film has not established scientifically sound and appropriate specifications, standards, sampling plans, and test procedures designed to assure that components conform to appropriate standards of identity, strength, quality, and purity [21 C.F.R . § 211.160(b)]. For example, the water used to provide the final rinse water during the cleaning of mixing tanks, which are used to make non sterile liquid product, is not tested to ensure that it meets the specifications for purified water.
Your response is inadequate in that your firm has not provided documentation to demonstrate that your firm's water system can produce purified water of adequate quality for your products.
3. Your firm has not cleaned and maintained equipment at appropriate intervals to prevent contamination that would alter the safety, identity, strength, or quality of the drug product [21 C.F.R. § 211.67(a)]. For example, the (b)(4) water system has not been validated. In addition, the (b)(4) used to transfer the deionized water from the (b)(4) water system to the mixing tanks is not cleaned.
We acknowledge your firm's commitment to reconfigure (b)(4) to "reduce or eliminate microbiological growth conditions," however your response does not specifically describe a plan for the reconfiguration of (b)(4), nor does your response describe additional training to be given to your employees.
Unapproved and Misbranded Prescription Drugs
In addition to the CGMP violations, you manufacture unapproved new drug in violation of the Act at your facility at 8810 Rehco Road, Suite F, San Diego, CA. Based on the information your firm submitted to FDA's Drug Registration and Listing System and the information collected during the inspection, you manufacture the following prescription drug, including, but not limited to:
• Treagan Otic
Treagan Otic is a drug 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 it is intended for use in the diagnosis, cure, mitigation, treatment, or prevention of diseases and because it is intended to affect the structure or function of the body. Further, this drug product, as marketed by your firm, is a "new drug" within the meaning of Section 201(p) of the Act [21 U.S.C. § 321(p)] because it is not generally recognized as safe and effective for its 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 on our information, there is no FDA-approved application on file for this drug product. The marketing of this product, or other applicable products, without an approved application constitutes a violation of these provisions of the Act.
Additionally, because the above product is 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 it so that a layman can use this product safely for its intended uses. Consequently, its labeling fails to bear adequate directions for its intended uses, causing it to be misbranded under section 502(f)(1) of the Act [21 U.S.C. § 352(f)(1)]. Because your product lacks a required approved application, it is 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 this product therefore violates Section 301(a) of the Act [21 U.S.C. §§ 331(a)].
The violations cited in this letter are not intended to be an all-inclusive statement of violations that exist at your facility. You are responsible for investigating and determining the causes of the violations identified above and for preventing their recurrence and the occurrence of other violations. It is your responsibility to assure compliance 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. Additionally, FDA may withhold approval of requests for export certificates, or approval of pending drug applications listing your facility, until the above violations are corrected. FDA may re-inspect to verify corrective actions have been completed.
Within fifteen 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 and copies of supporting documentation. If you cannot complete corrective action within fifteen working days, state the reason for the delay and the date by which you will have completed the correction. We also request that you outline the action you are taking to discontinue the marketing of the unapproved drug products at your facility, or any other applicable drug which you may market. Additionally, your response should state if you no longer manufacture or distribute products, and provide the date(s) and reason(s) you ceased production. Please note that if you are no longer marketing this (these) product(s), you must update the Drug Listing files in accordance with 21 C.F.R. § 207.30(a)(2).
Your reply should be sent to the attention of William Vitale, Compliance Officer, at the following address: Food and Drug Administration, Los Angeles District Office, 19701 Fairchild, Irvine, California 92612.
Sincerely,
/S/
Alonza E. Cruse
District Director
Los Angeles District
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