VIA UPS OVERNIGHT
Mr. Michael Segal, Chief Executive Officer
150 Pierce Street
Somerset, NJ 08873-4185 17-NWJ-11
Dear Mr. Segal:
From October 4, 2016 to October 24, 2016, U.S. Food and Drug Administration (FDA) investigators inspected your facility, PharmScript LLC, located at 150 Pierce Street, Somerset, NJ 08873-4185. During the inspection, 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 October 24, 2016. FDA acknowledges receipt of your facility’s responses dated November 4, 2016 and February 16, 2017. We also acknowledge your notice dated October 1, 2016, that states: “PharmScript has voluntarily suspended IV dispensing at our Somerset, NJ pharmacy (b)(4)” Based on this inspection, it appears that you produced drug products that violate the 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 noted that:
1. Your facility design is deficient for sterile drug production. Specifically, your firm’s (b)(4), where aseptic processing occurred, was located in an unclassified room. In addition, your firm produced and distributed drug products intended to be sterile for 5 consecutive days while the pressure of the (b)(4) was documented as “0.00.”
2. Your firm did not use a sporicidal agent or sterile wipes, and used a non-sterile disinfectant as part of your disinfection program for the aseptic processing areas.
3. Your firm failed to demonstrate through appropriate studies that your (b)(4) is able to provide adequate protection of the ISO 5 classified area in which sterile products are processed.
B. Corrective Actions
We have reviewed your firm's responses to the Form FDA 483.
Regarding the insanitary condition observations during the inspection, some of your corrective actions appear to be adequate. However, we are unable to fully evaluate the following corrective actions due to a lack of adequate supporting documentation:
1. We acknowledge your commitment to (b)(4). However, you did not provide any additional details or supporting documentation related to this (b)(4).
2. We acknowledge your commitment to use sterile wipes as well as a sporicidal agent with an appropriate frequency and contact time. In review of your response dated November 4, 2016, we noted that your SOP entitled (b)(4), instructs staff to use a germicidal detergent during (b)(4) cleaning of “all interior surfaces of the (b)(4).” However, you did not provide any additional information regarding this germicidal detergent and it is not clear if it is purchased sterile or sterilized prior to use in the aseptic processing areas. A non-sterile disinfectant may introduce spore contamination into the ISO 5 areas.
3. In response to our smoke studies observation, you provided your certification report, which states that the cleanroom visual smoke study occurred under dynamic conditions. However, this documentation is not sufficient for us to fully evaluate the adequacy of your response. Specifically, the report did not include a detailed description of the conditions at the time of the smoke studies. Therefore, it is not clear if production equipment was present or if routine production was simulated during the smoke study. We recommend that smoke studies under dynamic conditions be performed for all your ISO 5 (b)(4).
FDA strongly recommends that if you decide to resume production of sterile drugs, your management first undetake 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 processing expertise should assist you in conducting this comprehensive evaluation.
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 15 days prior to resuming production of any sterile drugs in the future.
Your written notification should refer to the Warning Letter Number above 17-NWJ-11. Please address your reply to:
Compliance Officer/OPQ Division 1
New Jersey District Office
10 Waterview Blvd., 3rd Floor
Parsippany, NJ 07054
If you have questions regarding the contents of this letter, please contact Liatte Krueger at 973-331-4933 or by email at email@example.com.
Division Director/OPQ Division 1
New Jersey District Office