| Public Health Service Food and Drug Administration |
| Rockville, MD 20857 |
Department of Health and Human Services
WARNING LETTER
Certified Mail
Return Receipt Requested
Mr. Richard Clark
Chairman, President & CEO
Merck & Co., Inc.
One Merck Drive
President Merck Drive
Whitehouse Station, NJ 08889
Dear Mr. Clark:
The Center for Veterinary Medicine (CVM), Food and Drug Administration (FDA), has reviewed information regarding Vetsulin (porcine insulin zinc suspension), New Animal Drug Application (NADA) Number 141-236, manufactured by Intervet Inc., a subsidiary of Merck & Co., Inc., located in Unterschleissheim, Germany. We found that Intervet Inc., failed to submit several Three-Day NADA/ANADA Field Alert Reports (FARs) for Vetsulin, as required by Title 21, Code of Federal Regulations (CFR), Part 514.80.
Specifically, we found that Intervet Inc., did not comply with the reporting requirements in 21 CFR 514.80(b)(1). This regulation states that applicants must submit information pertaining to product and manufacturing defects that may result in serious adverse drug events to the appropriate FDA District Office or local FDA resident post within three working days of first becoming aware that a defect may exist. The information initially may be provided by telephone or other telecommunication means, with prompt written follow-up using Form FDA 1932 "Veterinary Adverse Drug Reaction, Lack of Effectiveness, Product Defect Report."
Analytical testing conducted by Intervet Inc., revealed several batches of Vetsulin did not meet stability specifications for non-extractable insulin before the end of the drug's expiration date. FDA's approvals are conditioned on approved product specifications, such as stability, and therefore, the safety and effectiveness of products outside approved specifications are unknown. Insulin products with product defects such as nonconformance with stability specifications may result in a serious adverse drug event, and therefore are subject to the FAR requirements in 21 CFR 514.80(b)(1). Although Intervet Inc., was aware that analytical data for batch numbers (b)(4), and (b)(4) of Vetsulin showed out of specification results for non-extractable insulin, you did not submit FARs within three working days of first becoming aware of this information. Failure to submit such required reports is a prohibited act under section 301(e) of the Act, 21 [USC 331(e)]. The violations cited in this letter are not intended to be an all-inclusive list of violations that exist in connection with your product. 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 that you comply 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.
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 the violation. Include an explanation of each step being taken to prevent the recurrence of the violation, as well as copies of related documentation. If you cannot complete corrective action within fifteen (15) working days, state the reason for the delay ad the time within which you will complete the correction.
Please send your written reply to the Food and Drug Administration, Attention: Mr. Jonathan Bray, 7519 Standish Place (HFV-232), Rockville, MD 20855. If you have questions regarding any issue in this letter, please contact Mr. Bray at (240) 276-9228.
Sincerely your,
/S/
Neal Bataller, ME, DVM,
Director, Division of Compliance
Center for Veterinary Medicine
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