Source: https://www.fda.gov/inspections-compliance-enforcement-and-criminal-investigations/warning-letters/vann-healthcare-services-inc-04292015
Timestamp: 2020-06-03 23:58:11
Document Index: 603409603

Matched Legal Cases: ['§ 353', '§ 351', '§ 352', '§ 355', '§ 351', 'arts 210', '§ 201', '§ 331', 'arts 210', 'art 211']

Vann Healthcare Services Inc - 04/29/2015 | FDA
Vann Healthcare Services Inc - 04/29/2015
Vann Healthcare Services Inc April 29, 2015
WARNING LETTER CIN-15-449139-18
Evin P. Vann, President
Vann Healthcare Services, Inc.
Glasgow, KY 42141-3462
From September 8, 2014, to September 24, 2014, a U.S. Food and Drug Administration (FDA) investigator conducted an inspection of your facility, Vann Healthcare Services, Inc., located at 1220 North Race Street, Glasgow, KY 42141-3462. During the inspection, the investigator noted that you were not receiving valid prescriptions for individually-identified patients for a portion of drug products you were producing. In addition, the investigator observed serious deficiencies in your practices for producing sterile drug products, which put patients at risk. For example, the investigator observed that your operator produced sterile drug products with exposed skin on (b)(6) wrists and upper chest. In addition, your firm did not use a sporicidal agent to disinfect the ISO 5 area. Furthermore, the investigator found that your firm failed to demonstrate through appropriate studies that your hood is able to provide adequate protection of the ISO 5 area in which sterile drug products are produced. Therefore, your products may be produced in an environment that poses a significant contamination risk. FDA issued a Form FDA 483 to your firm on September 24, 2014.
Section 503A of the FDCA [21 U.S.C. § 353a] describes the conditions under which certain compounded human drug products are entitled to exemption from three sections of the FDCA: compliance with current good manufacturing practices (CGMP), section 501(a)(2)(B) of the FDCA [21 U.S.C. § 351(a)(2)(B)]; labeling with adequate directions for use, section 502(f)(1) of the FDCA [21 U.S.C. § 352(f)(1)]; and FDA approval prior to marketing, section 505 of the FDCA [21 U.S.C. § 355]. Receipt of valid prescriptions for individually-identified patients is one of the conditions for the exemptions under section 503A of the FDCA.
During the FDA inspection, the investigator observed that your firm does not receive valid prescriptions for individually-identified patients for a portion of the drug products you produce. Accordingly, the drugs you compound without valid prescriptions for individually-identified patients are not entitled to the exemptions in section 503A of the FDCA.[1]
In addition, your drug products that are intended or expected to be sterile were prepared, packed, or held under insanitary conditions whereby they may have been contaminated with filth, or whereby they may have been rendered injurious to health causing them to be adulterated within the meaning of section 501(a)(2)(A) [21 U.S.C. § 351(a)(2)(A)] of the FDCA. Furthermore, because you manufacture and distribute drugs without valid prescriptions for individually-identified patients, the manufacture of those drugs is also subject to FDA’s Current Good Manufacturing Practice (CGMP) regulations for Finished Pharmaceuticals, Title 21, Code of Federal Regulations (CFR), Parts 210 and 211. The FDA investigator observed significant CGMP violations at your facility, causing your drug products to be adulterated within the meaning of section 501(a)(2)(B) of the FDCA.
Because the drug products for which you have not obtained valid prescriptions for individually-identified patients 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 these products 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)(1) of the FDCA, and they are not exempt from the requirements of section 502(f)(1) of the FDCA (see, e.g., 21 CFR § 201.115). It is a prohibited act under section 301(k) of the FDCA [21 U.S.C. § 331(k)] to do any act with respect to a drug, if such act is done while the drug is held for sale after shipment in interstate commerce and results in the drug being misbranded.
Additionally, the FDA investigator observed that your sterile drug products were prepared, packed, or held under insanitary conditions, whereby they may have become contaminated with filth or rendered injurious to health, causing your drug products to be adulterated under section 501(a)(2)(A) of the FDCA. For example, the investigator observed that your operator produced sterile drug products with exposed skin on (b)(6) wrists and upper chest. In addition, your firm did not use a sporicidal agent to disinfect the ISO 5 area. Furthermore, the investigator found that your firm failed to demonstrate through appropriate studies that your hood is able to provide adequate protection of the ISO 5 area in which sterile drug products are produced. Therefore, your products may be produced in an environment that poses a significant contamination risk.
Your firm failed to clean and, where indicated by the nature of the drug, sterilize and process container closures to remove pyrogenic properties to assure they are suitable for their intended use (21 CFR 211.94(c)).
FDA acknowledges your voluntary recall of all sterile products within expiry and acknowledges receipt of your response to the Form FDA 483, dated October 6, 2014, in which you stated that your firm ceased sterile operations on October 6, 2014. If you decide to resume production of sterile drugs, FDA strongly recommends that your management undertake a comprehensive assessment of your operations, including facility design, procedures, personnel, processes, materials, and systems. In particular, this review should assess your aseptic processing operations. A third party consultant with relevant sterile drug manufacturing expertise could be useful in conducting this comprehensive evaluation.
Please be aware that section 501(a)(2)(A) of the FDCA concerning insanitary conditions applies regardless of whether the drugs are compounded and distributed after receipt of a prescription for an identified individual patient. You must correct all insanitary conditions at your firm before you resume operations.
In addition, if you continue to manufacture and dispense drug products without valid prescriptions for individually-identified patients, the manufacture of such drugs would be subject to FDA’s drug CGMP regulations (21 CFR Parts 210 and 211), among other requirements described above, and, before doing so, you should fully implement corrections that meet the minimum requirements of 21 CFR Part 211 in order to provide assurance that the drug products produced by your firm conform to the basic quality standards that ensure safety, identity, strength, quality, and purity.
In addition, you should correct the violations of section 502(f)(1) of the FDCA, noted above.
Stephen Rabe, Compliance Officer
FDA Cincinnati District Office
If you have questions regarding any issues in this letter, please contact Mr. Rabe via email at stephen.rabe@fda.hhs.gov or by phone at 513-679-2700, ext. 2163.
Douglas T. Heitkemper
[1]The Compounding Quality Act (CQA) contains a number of other provisions, including new exemptions and requirements for compounders seeking to operate as outsourcing facilities. A discussion of the CQA and the agency’s plans to implement the new law may be found at http://www.fda.gov/Drugs/GuidanceComplianceRegulatoryInformation/PharmacyCompounding/default.htm.