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September 25, 2020

Case # 610467

WARNING LETTER

Mr. Palan:

From July 30, 2019, to August 9, 2019, a U.S. Food and Drug Administration (FDA) investigator inspected your facility, Medoz Pharmacy of Polk Inc., located at 40230 Highway 27, Suite 100, Davenport, Florida 33837. During the inspection, the investigator noted serious deficiencies in your practices for producing sterile drug products, which put patients at risk.

FDA issued a Form FDA 483 to your firm on August 9, 2019. FDA acknowledges receipt of your facility’s response, dated August 22, 2019. FDA also acknowledges your statement that you ceased sterile compounding and voluntarily relinquished your Florida Department of Health sterile compounding permit effective August 2, 2019. Based on this inspection, it appears that you produced drug products that violate the Federal Food, Drug, and Cosmetic Act (FDCA).

A. Compounded Drug Products Under the FDCA

Section 503A of the FDCA describes the conditions under which human drug products compounded by a licensed pharmacist in a State licensed pharmacy or a Federal facility, or a licensed physician, qualify for exemptions from three sections of the FDCA: compliance with current good manufacturing practice (CGMP) (section 501(a)(2)(B)); labeling with adequate directions for use (section 502(f)(1)); and FDA approval prior to marketing (section 505) [21 U.S.C. §§ 351(a)(2)(B), 352(f)(1) and 355(a)].¹ Receipt of valid prescriptions for individually-identified patients is one of the conditions for the exemptions under section 503A.

B. Violations of the FDCA

Adulterated Drug Products

The FDA investigator noted that 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 [21 U.S.C. § 351(a)(2)(A)]. For example, the investigator observed that:

1. Your firm’s cleanroom, anteroom, and non-sterile suite contained vermin including numerous dead ants, living spiders, and a dead cockroach. In addition, a colony of dead ants was observed on (b)(4) bag containing sterile stoppers located in the unclassified area.

2. Your firm handled hazardous drug products without providing adequate containment, segregation, and cleaning of work surfaces and utensils to prevent cross-contamination.

3. Your firm’s ISO 5 classified aseptic processing areas contained visibly dirty equipment and surfaces, including an ISO 5 work surface that was observed with blue stains during aseptic production.

4. Your cleanroom contained difficult to clean surfaces. Specifically, your cleanroom flooring located in front of the biological safety cabinet contained cracks.

5. Your firm’s personnel donned gowning apparel improperly, in a way that may have caused the gowning apparel to become contaminated. In addition, an operator exposed their bare hands within the ISO 5 work area while donning gloves in preparation for aseptic production.

6. Your firm’s aseptic operator manually contacted the inner surfaces of stoppers during aseptic production.

7. Your firm’s cleanrooms contained HEPA filters that were stained, contained gaps between the ceiling and the HEPA frame, and had chipping paint surrounding the ceiling frame.

8. Your firm did not use a sporicidal agent in the ISO 5 areas.

9. Your firm failed to perform adequate smoke studies under dynamic conditions to demonstrate unidirectional airflow within the ISO 5 area. Therefore, your products intended to be sterile are produced in an environment that may not provide adequate protection against the risk of contamination.

Under section 301(a) of the FDCA [21 U.S.C. § 331(a)], the introduction or delivery for introduction into interstate commerce of any drug that is adulterated is a prohibited act. Further, 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 adulterated.

C. Corrective Actions

We have reviewed your firm’s response to the Form FDA 483. We acknowledge your statement that you ceased sterile compounding and voluntarily relinquished your Florida Department of Health sterile compounding permit effective August 2, 2019.

Please be aware that section 501(a)(2)(A) of the FDCA concerning insanitary conditions applies regardless of whether drug products you compound meet the conditions of section 503A.FDA strongly recommends that if you decide to resume production of sterile drugs, your management first undertake a comprehensive assessment of operations, including facility design, procedures, personnel, processes, maintenance, materials, and systems. In particular, this review should assess your aseptic processing operations. A third-party consultant with relevant sterile drug manufacturing expertise should assist you in conducting this comprehensive evaluation.

D. Conclusion

The violations cited in this letter are not intended to be an all-inclusive statement of violations at your facility. 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 ensure that your firm complies with all requirements of federal law, including FDA regulations.

If you decide to resume sterile operations, 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.

Within fifteen (15) working days of receipt of this letter, please notify this office in writing if you have taken any specific steps to correct the violations cited in this letter, or you may inform us that you do not intend to resume production of sterile drugs. If you intend to resume production of sterile drugs in the future, please include an explanation of each step being taken to prevent the recurrence of violations, as well as copies of related documentation. If you do not believe that the products discussed above violated the FDCA, include your reasoning and any supporting information for our consideration. In addition to taking appropriate corrective actions, you should notify this office fifteen (15) days prior to resuming production of any sterile drugs in the future.

Please identify your response with FEI 3015316526. Send your electronic reply to Dr. Shawn Larson – Compliance Officer at [email protected] and [email protected].

If you have questions regarding the contents of this letter, please contact Dr. Larson at 214-253-5216.

Sincerely,
/S/

Monica R. Maxwell
Program Division Director
Office of Pharmaceutical Quality Operations,
Division II

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1 We remind you that there are conditions other than those discussed in this letter that must be satisfied to qualify for the exemptions in section 503A of the FDCA.