Specifically

(A) Your environmental monitoring (EM) of the ISO 5 Laminar Airflow Hood (LAFH) in Sterile Non-Hazardous Drug Suite and the ISO 5 Biological Safety Cabinet (BSC) in Sterile Hazardous Drug Suite is not performed on a frequent basis to demonstrate that the ISO 5 environment is adequate for the production of sterile drugs. EM was conducted on *** basis including viable air sampling and surface sampling. For example, your firm performed EM in Sterile Hazardous Drug Suite on 6/21/2023 and 7/18/2023 and in Sterile Non-Hazardous Drug Suite on 6/14/2023 and 7/14/2023. Non-viable air monitoring is conducted *** during qualification of ISO classified areas. For example, the two most recent certifications of LAFH were issued on *** and ***; however, no EM was conducted during manufacturing of each batch. During the period of 7/24/2023 to 8/23/2023, your firm received *** prescription orders for sterile compounded drug products. For example, your firm produced Atipamezole Hydrochloride @***Mg/ML Injection, Lot# 04252023@*** on 4/25/2023 and Lot # 05252023*** on 5/25/2023. No EM was performed during aseptic compounding process for these batches.

(B) Personnel monitoring does not follow your procedure. According to your SOP 3.03, Environmental Monitoring of the Cleanroom Facilities, Version Number 17.0, personal gloves shall be sampled at least ***, including when sterile compounding personnel complete, a *** sterile compounding medial fill, after garbing and prior to disinfecting gloves; however, your firm sampled personal gloves for microbiological testing only during media fill but not on a *** basis per your SOP requirement. For example, Technician *** sampled gloves on 1/20/2023 and 7/5/2023 during media fill for sterile non-hazardous compounded drugs, but there was no *** sampling conducted in 2023. Also, personnel monitoring is not performed during the manufacturing of each batch.

(C) On 8/23/2023, during the compounding of Acetyl-D-Glucosamine In Water for INJ, 200 MG/ML Injectable, Lot#08232023@*** in the Sterile Non-Hazardous Drug Suite, it was observed sealed *** bags containing vials, stoppers or utensils placed in a movable cart in the ISO 7 buffer room were introduced into the ISO 5 LAFH one at a time by Technician ***, and then the outer layer of each bag was removed by Technician ***; however, surfaces of each outer layer bag were not sanitized with *** prior to be introduced into the ISO 5 LAFH by Technician ***.

(D) During aseptic compounding of Acetyl-D-GIucosamine In Water for INJ, 200 MG/ML Injectable, Lot#08232023@*** in the Sterile Non-Hazardous Drug Suite on 8/23/2023 and Histrelin (As Histrelin Acetate) @ 0.5 mg/ml Injection, Lot # 08252023@***in the Sterile Hazardous Drug Suite on 8/25/2023, it was observed on both occasions Technicians forehead was not fully covered by a hairnet and hair on the back of the neck was exposed.

(E) There is no air return vent in the Sterile Non-Hazardous Drug Suite. The return air blows out from the ISO 7 cleanroom directly to the unclassified non-sterile drug production area through an air filter taped on from the outside on all four sides of this cleanroom suite.

(F) Your firm has not established and/or validated a hold time for supplies after depyrogenation. Your firm performed in-house depyrogenation of beakers and utensils used for producing sterile compounded animal drug products. For example, your firm used the depyrogenated glass beaker wrapped with *** to produce Detomidine HCL/Xylazine 2.5Mg/100Mg/ML Injectable, Lot#05052023@*** on 5/5/2023;

Your firm stated that in general, a beaker after depyrogenation could be held for ***; however this hold time has not been well established and validated. Also, your firm has established a *** hold time for vials placed in a pouch by operators used for producing sterile compounded drug products. For example, your firm produced Xylazine In Water For Injection@333 Mg/MI Injectable, Lot#04192023@*** on 4/19/2023 using a depryogenated *** dated 3/27/2023; however, you have not validated the *** hold time.