- Delivery Method:
- VIA UPS
Recipient NameJoseph Pierro
- Sharp Drugs, Inc. dba Island Drug and Surgical
8C Moniebogue Lane
West Hampton Beach, NY 11978-2613
- Issuing Office:
- Division of Pharmaceutical Quality Operations I
10 Waterview Blvd, 3rd Floor
Parsippany, NJ 07054
CMS # 588331
August 2, 2019
Dear Mr. Pierro:
From July 10, 2018, to July 13, 2018, a U.S. Food and Drug Administration (FDA) investigator inspected your facility, Sharp Drugs, Inc. dba Island Drug and Surgical, located at 8C Moniebogue Lane, West Hampton Beach, NY 11978-2613. 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 July 13, 2018. FDA acknowledges receipt of your facility’s response, dated August 1, 2018. FDA also acknowledges that on July 18, 2018, your firm voluntarily ceased all sterile production. Based on this inspection, it appears that you produced drug products that violate the FDCA.
Specific violations are described below.
A. Violations of the FDCA
Adulterated Drug Products
The FDA investigator 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 investigator observed the following insanitary conditions at your facility:
Your biological safety cabinet (BSC) used for the processing of sterile drug products is located in a non-classified room that lacks a HEPA filtration system.
Your BSC is turned off when not in use and is not re-cleaned before sterile processing.
Your cleaning of the BSC was conducted using non-sterile (b)(4) applied with non-sterile disposable paper towels.
Non-sterile (b)(4) wipes were used on each vial stopper and IV bag ports during sterile processing.
No sporicidal agent was used within your ISO 5 aseptic processing area.
The investigator also observed that the gloves worn during sterile processing were non-sterile, and that materials used for the production of sterile drug products were transferred into the BSC without being disinfected.
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.
No media fills have been performed by your firm. Therefore, there is a lack of assurance that your firm can aseptically produce drug products within your facility.
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
We have reviewed your firm’s responses to the Form FDA 483. We acknowledge your statements, in your July 18, 2018 letter, that your firm has “ceased all sterile compounding…until such time as when our sterile compounding environment is up to regulatory standards,” and in your July 20, 2018, letter, that your firm will notify FDA “before [resuming] any sterile compounding.”
If your firm decides to resume processing of sterile drugs in the future at the facility we inspected or another facility, FDA strongly recommends that your management first undertake a comprehensive assessment of your operations, including facility design, procedures, personnel, processes, maintenance, materials, and systems. In particular, this review should assess your aseptic processing operations and design. A third party consultant with relevant sterile drug production expertise should assist you in conducting this comprehensive evaluation.
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. If you decide to resume sterile operations, you must correct all insanitary conditions at your firm.
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.
Send your electronic response to email@example.com. Your written notification should refer to the Warning Letter Number above (#588331).
If you have any questions, contact Compliance Officer, Barbara Wilimczyk-Macri at firstname.lastname@example.org or 973-331-4951.
Program Division Director/District Director
Office of Pharmaceutical Quality Operations
Division I/New Jersey District