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U.S. Department of Health and Human Services

Inspections, Compliance, Enforcement, and Criminal Investigations

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Shamrock Medical Solutions Group LLC 6/15/12


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

Public Health Service
Food and Drug Administration
Cincinnati District Office
Central Region
6751 Steger Drive
Cincinnati, OH 45237-3097
Telephone: (513) 679-2700
FAX: (513) 679-2761 


June 15, 2012
John P. Reichard, President, COO
Shamrock Medical Solutions Group, LLC
741 Radio Drive
Lewis Center, OH 43035
Dear Mr. Reichard:
During our August 3-24, 2011 inspection of your pharmaceutical manufacturing facility, Shamrock Medical Solutions Group, LLC, located at 741 Radio Drive, Lewis Center, Ohio, investigators 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 violations cause your drug products 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 firm mislabeled drug products causing them to be misbranded under section 502(b)(2) of the Act [21 U.S.C. § 352(b)(2)]. By introducing adulterated and misbranded drugs into interstate commerce you are in violation of section 301(a) of the Act [21 U.S.C. § 331(a)].
Specific violations observed during the inspection include, but are not limited to, the following:

1. Your firm has failed to exercise appropriate controls over computer or related systems to assure that changes in master production and control records, or other records, are instituted only by authorized personnel [21 C.F.R § 211.68(b)].

For example, repackaging technicians changed master labels of repackaged products, which resulted in product packages labeled with incorrect strength or incorrect spelling of the drug name. You then released these mislabeled drug products for distribution. Examples of incorrect labeling that resulted from technicians changing the master label include: Levothyroxine Sodium 150 mcg Tablet labeled as Levothyroxine Sodium 150 mg Tablet, and Metoclopramide 10 mg/10 ml labeled as Metroclopramide 10 mg/10 ml. Your firm included a proposal to revise the labeling system computer software to restrict technicians’ access to the master labeling program in the Corrective and Preventative Actions (CAPA) sections of four separate Incident Reports concerning mislabeled products. These proposals were signed and submitted for approval to your Quality Assurance Unit (QAU) on March 31, 2011. However, to date, your firm has not reported any corrective or preventive actions taken to address these violations. We also note that you did not follow your SOP S-0002.00-PROD “Master Production and Control Record,” which requires your Quality Assurance Unit (QAU) or designee to review each master production and control record before beginning repackaging and/or relabeling operations. These records include the drug product name, strength, and dosage form, as well as copies of each label. However, your QAU review was inadequate in that the error was not noted. 

2. Your firm 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.F.R. § 211.100(a)]. 

For example, you do not have any written procedures for the manual repackaging of liquid drugs into oral syringes or fluid dose cups. Absent such a procedure, you do not have a process to ensure that the repackaged containers are properly filled. Consequently, you have received complaints from customers that products contained air bubbles and had low fill volumes. The subject of these complaints included a lot of oxycodone hydrochloride oral solution and seven lots of morphine sulfate oral solution. To date, you have not reported any corrective or preventive actions to address these violations.

3. Your firm has failed to follow written responsibilities and procedures applicable to the quality control unit [21 C.F.R. § 211.22(d)]. For example,

a. Your QAU failed to follow SOP S-0005.00-QC “Lot Release” that requires your QAU to review and approve the release of all drug lots your firm repackages. Your QAU released Diltiazem HCl 120 mg extended-release capsule unit-dose packages mislabeled as Diltiazem HCl 250 mg extended-release capsule. 
b. Your QAU failed to follow SOP S-0008.00-ADM "Quality Assurance Unit," that requires your QAU to review production batch records. Production records show that you repackaged several lots of drug products without conducting all required in-process sampling and weight checks. For five different manually filled products, you lack documentation in the batch record for sampling and weight checks for several lots. For products that you fill/repackage using the (b)(4), the batch record demonstrates that you did not sample and weigh lots at the interval required by SOP S-0012.00 EQ “Operation of the (b)(4)” to ensure the accuracy of the fill. Your QAU released these lots despite this deficiency. To date, you have not reported any corrective or preventive actions that you have taken to address these violations.

4. Your firm has failed to prepare batch production and control records with complete information relating to production and control for each batch of drug product [21 C.F.R. § 211.188].

For example, your firm failed to include yield calculations, or to identify who performed or verified yield calculations for batch production records for several lots of various drug products that were repackaged and released. To date, you have not reported any corrective or preventive actions that you have taken to address these violations.
In addition to the CGMP violations, your firm violated the Act by introducing misbranded drugs into interstate commerce. Our investigator found that during your repackaging process, you mislabeled prescription drugs, including, but not limited to, the following:
 Levothyroxine Sodium Tablet, 0.15 mg; mislabeled as "150 mg"
 Diltiazem HCI ER Capsule, 120 mg; mislabeled as "250 mg"
 Metoclopramide Oral Solution 10mg/10mL ; mislabeled as "Metroclopramide"
As labeled, the Levothyroxine Sodium 0.15 mg tablet and the Diltiazem HCl ER 120 mg Capsule drug products were misbranded within the meaning of section 502(b)(2) of the Act [21 U.S.C. §§ 352(b)(2)] in that the labels for these packaged drug products did not bear an accurate statement of the quantity or the contents in terms of weight, measure, or numerical count. Furthermore, as labeled, the Metroclopramide Oral Solution 10mg/10mL drug product was misbranded within the meaning of section 502(e)(1)(A)(i) of the Act [21 U.S.C. §§ 352(e)(1)(A)] in that the label did not bear the established name of the drug.
We have reviewed your firm’s response dated August 23, 2011, and note that it lacks sufficient corrective actions. We also acknowledge receipt of your May 17, 2012 written response to the Form FDA 483. However, because this response was received more than 15 business days after the Form FDA 483 was issued, the response has not been considered. We plan to evaluate your response to the Form FDA 483, along with any other written material provided, as a direct response to this warning letter.
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. Additionally, your response should state if you no longer manufacture or distribute the drug products manufactured at this facility, and provide the dates and reasons you ceased production. If you no longer manufacture or distribute the drug products, indicate your progress in updating the Drug Listing files in accordance with 21 C.F.R. 207.30(a)(2). 
Your reply should be sent to the following address:
Stephen J. Rabe
Food and Drug Administration
Cincinnati District Office
Central Region
6751 Steger Drive
Cincinnati, OH 45237-3097
If you have any questions about the content of this letter, please contact Mr. Rabe at 513-679-2700 ext. 2163.
Paul J. Teitell
District Director
Cincinnati District