(1) Your firm’s containment control and monitoring programs are inadequate to address the possibility of cross contamination of *** pharmaceutical products (i.e. *** APIs and finished dosage forms) with the *** and vice versa. Prior to introducing *** on site on *** and beginning manufacturing operations for *** in *** on November 28, 2023, the following controls were not established:

(a) Your firm did not develop and implement an analytical method capable of detecting cross contamination of *** in the *** products.

(b) Your firm did not develop and implement an analytical method capable of detecting the presence of cross contamination of *** in the *** manufacturing facilities *** nor have you identified appropriate monitoring locations to assess or potential cross contamination.

(c) Your firm did not establish/validate a deactivation agent for decontamination of the product *** product or a contingency (corrective action) procedure that will be implemented if contamination is found which exceeds established acceptable limits in the manufacturing blocks or other common areas.

(2) Prior to introducing *** your firm did not establish thorough containment practices regarding the handling and movement of personnel, equipment, and materials, through common areas. For example:

(a) Your firm also did not restrict personnel working in the *** manufacturing block *** from entering the manufacturing blocks on the same day, and vice versa. Your firm did not have dedicated personnel for each facility. Your procedure, EP2-PLC-SOP-001-01, “Plant Entry and Exit”, does not state that personnel working in one block cannot enter the other.

(b) The QC and microbiology laboratories are shared between the *** facilities. The microbiology laboratory is located in the *** block where *** is manufactured. Microbiology samples (EM, bioburden, *** etc.) taken in the *** block are incubated and read using shared incubators and laboratory areas with the *** block. Personnel entering in the laboratory are not restricted from entering production buildings and common areas used be production employees.

(c) Paper batch production and control records and environmental monitoring records for *** products were moved from their respective manufacturing blocks through the campus to the administration building for storage. New documents issued to the respective manufacturing blocks are issued from this shared document control area. Personnel working in the administrative and document control area are not restricted from entering production buildings and common areas used by production employees.

(d) Tools such as hammers, wrenches, screwdrivers, etc. which are used to perform general maintenance and repairs throughout the campus and all manufacturing blocks are not dedicated to *** areas. Maintenance personnel working in the area where tools are stored are not dedicated and are not restricted from entering production buildings.

(e) There are separate canteens for workers to use for meal breaks; however, the entrances to these canteens have no controls to prevent workers in the *** block from using the same canteen as those working in the *** blocks, and vice versa.

(f) Your firm constructed a new manufacturing / filling block *** for filling the product *** injection. This *** manufacturing block and the manufacturing block for *** are separated by ***. The warehouse entrances for receiving material are located ***.

(g) Personnel working in the *** production areas pass through a common plant entry and exit area.

(h) Facility meeting and conference rooms are common areas between employees that have been in *** areas. Personnel that have been in these common areas are not restricted from entering production areas.