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WARNING LETTER

WL # 608320

June 9, 2020

Dear Ms. Malanda:

From June 17, 2019, to July 25, 2019, U.S. Food and Drug Administration (FDA) investigators inspected your facility, Malanda, Inc. dba Mandell’s Clinical Pharmacy, located at 7 Cedar Grove Lane, Suite 20, Somerset, NJ 08873. 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 July 25, 2019. FDA acknowledges receipt of your facility’s response, dated August 12, 2019, as well as your subsequent correspondence. FDA further acknowledges that your firm agreed to cease using the “Laminar Flow (b)(4)” and will not resume its use until “such use will be in conformity with all state and federal statutes and related regulations.” 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 investigators 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. For example, the investigators observed that:

1. Your firm processed drug products intended to be sterile within an ISO 5 classified laminar flow (b)(4) that is located within an uncontrolled, non-classified work environment. In addition, the investigators observed water dripping from an 8-foot-high ceiling vent located in the same room, within 15-feet of the (b)(4).

2. Your firm was not using a sporicidal agent to disinfect your facility’s ISO 5 areas, and when it was used to disinfect the ISO 7 areas, a contact time was not established.

3. Your firm used a non-sterile (b)(4) to mix a solution during the processing of a drug product intended to be sterile.

4. Your firm handled hazardous drug products without providing adequate containment, segregation, or cleaning of work surfaces and utensils to prevent cross-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 responses. Regarding your responses related to the insanitary conditions, some of your proposed corrective actions appear adequate. However, we cannot fully evaluate the adequacy of the following corrective actions because you did not include sufficient information or supporting documentation:

1. In response to Observation 1, pertaining to the location of the ISO 5 classified laminar flow (b)(4), FDA acknowledges that your firm agreed to cease using the “Laminar Flow (b)(4)” and will not resume its use until “such use will be in conformity with all state and federal statutes and related regulations.” Provide an update on this commitment. If you have resumed aseptic production within the (b)(4), provide supporting documentation, such as the classification of the surrounding environment, as well as the beyond-use-dates assigned to products produced within the (b)(4).

2. In response to Observation 4, pertaining to sporicidal use within classified areas, you did not provide updated cleaning procedures that are specific to the use of sporicidal agents in your facility’s ISO 5 areas and other classified areas.

3. In response to Observation 3, pertaining to non-sterile equipment used in sterile drug production, you did not provide updated procedures specific to ensuring that equipment used during sterile drug production does not add pyrogenic properties to the sterile drug products.

4. In response to Observation 5, pertaining to cross-contamination concerns, you did not provide procedures specific to the addition of deactivation and decontamination agents to the cleaning program.

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 your management 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.

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 of the specific steps that you have taken to correct violations. 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 are in violation of the FDCA, include your reasoning and any supporting information for our consideration. If you cannot complete corrective action within fifteen (15) working days, state the reason for the delay and the time within which you will complete the correction.

Send your electronic response to [email protected]. Your written notification should refer to the Warning Letter Number above (# 608320). If you have questions regarding the contents of this letter, please contact Nancy Scheraga at [email protected].

Sincerely,
/S/

Diana Amador-Toro
Program Division Director/District Director
Office of Pharmaceutical Quality Operations
Division I/New Jersey District

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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.