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January 13, 2020

CMS Case # 598303

WARNING LETTER

Mr. Anderson:

From March 26, 2019, to April 5, 2019, U.S. Food and Drug Administration (FDA) investigators inspected your facility, Anderson Compounding Pharmacy, Inc. dba Anderson Compounding Pharmacy, located at 310 Bluff City Hwy, Bristol, Tennessee 37620. The investigators 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 April 5, 2019. FDA acknowledges receipt of your facility’s response, dated April 25, 2019, in which you stated that “[e]ffective March 25, 2019, the Pharmacy voluntarily ceased sterile compounding of human and veterinary drugs.” FDA also acknowledges your voluntary recall, initiated on April 2, 2019, of all drug products intended to be sterile produced from September 25, 2018, to March 25, 2019, due to lack of sterility assurance.

Based on this inspection, it appears that you produced drug products that violate the Federal Food, Drug, and Cosmetic Act (FDCA).

A. Violations of the FDCA

Adulterated Drug Products

The FDA investigators noted that drug products intended or expected to be sterile 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 investigators observed that:

1. Your ISO 5 classified aseptic processing areas had difficult to clean and visibly dirty surfaces.

2. Your cleanroom and anteroom contained non-microbial contamination and difficult to clean surfaces.

3. Your cleanroom had unsealed, loose ceiling tiles directly above the ISO 5 classified aseptic processing areas and (b)(4).

4. 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 were produced in an environment that may not have provided adequate protection against the risk of contamination.

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.

B. Corrective Actions

FDA acknowledges your voluntary recall, initiated on April 2, 2019, of all drug products intended to be sterile produced from September 25, 2018, to March 25, 2019, due to lack of sterility assurance. In addition, we acknowledge that your firm ceased sterile drug production on March 25, 2019 and does not anticipate resuming sterile drug production. Further, FDA acknowledges your firm’s response to the Form FDA 483, dated April 25, 2019.

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.

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 and notify the FDA prior to resuming operations. 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) working days prior to resuming production of any sterile drugs in the future.

Your written notification should refer to the Warning Letter Number 598303.

Please electronically submit your reply, on company letterhead, to Jamillah Selby, Compliance Officer, at ORAPHARM2_RESPONSES@fda.hhs.gov. In addition, please submit a signed copy of your response to jamillah.selby@fda.hhs.gov and john.diehl@fda.hhs.gov.

If you have questions regarding the contents of this letter, you may contact Mrs. Selby via phone at 214-253-5218 or email at jamillah.selby@fda.hhs.gov.

Sincerely,
/S/

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

CC:
Reginald Dilliard, DPH
Executive Director
Tennessee Board of Pharmacy
665 Mainstream Drive
Nashville, Tennessee 37243