EXHIBIT 99.2
| DEPARTMENTOFHEALTH AND HUMAN SERVICES |
| FOOD AND DRUG ADMINISTRATION |
| DISTRICT ADDRESS AND PHONE NUMBER | DATE(S) OF INSPECTION |
| | | | | | 1/23/2019-2/13/2019* |
| 158-15 Liberty Avenue | | | | |
| Jamaica, NY 11433 | FEI NUMBER | | | |
| (718) 340-7000 Ext:5301 Fax:(718)662-5661 | 2433247 | | | |
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| NAME AND TITLE OF INDIVIDUALTO WHOM REPORT ISSUED |
| Eyal Mares, Vice President and General Manager Amityville Operations |
| FlRM NAME | STREET ADDRESS |
| Hi-Tech Pharmacal Co. Inc., An AKORNCompany | 369 Bayview Ave |
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| CITY, STATE, ZIP CODE, COUNTRY | TYPE ESTABLISHMENT INSPECTED |
| Amityville, NY 11701-2801 | Human Sterile and Non-Sterile Drug Manufacturer |
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| This document lists observations made by the FDA representative(s) during the inspection of your facility. They are inspectional observations, and do not represent a final Agency determination regarding your compliance. If you have an objection regarding an observation, or have implemented, or plan to implement, corrective action in response to an observation, you may discuss the objection or action with the FDA representative(s) during the inspection or submit this information to FDA at the address above. If you have any questions, please contact FDA at the phone number and address above. |
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| DURING AN INSPECTION OF YOUR FIRM I OBSERVED: |
| OBSERVATION 1 |
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| Records are not kept for the maintenance, cleaning, sanitizing and inspection of equipment. |
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| Specifically, you did not have any records to adequately demonstrate that the transfer hose connected between the tote and the filling machine was maintained, cleaned, sanitized, and inspected prior to the filling of the finished drug product. The transfer hose is the final step where the finished drug product is transferred from the tote to the filling machine for final fill. |
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| OBSERVATION 2 |
| Aseptic processing areas are deficient regarding systems for maintaining any equipment used to control the aseptic conditions. |
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| Specifically, during review of the media fill for in Room S3-104 and in Room 101, on January31, 2019, I observed sterile pump parts, initially opened from their autoclave pouches, underneath a metal cart, shielded from the HEPA filtered vertical air flow within the ISO 5 environment. In Room 101, the pump was put together by a Sterile Mechanic inside an ISO 5 Laminar Air Flow Tent, and the pump is required to maintain the suspension as it flows through the pump and kettle during the final fill process in Room S3-104 with the Cozzoli Filler. |
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OBSERVATION 3 |
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| SEE REVERSE OF THIS PAGE | EMPLOYEE(S) SIGNATURE | DATE ISSUED |
| | Jay T Wong, Investigator | |  | 2/13/2019 |
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| FORM FDA 483 (09/08) | PREVIOUS EDITION OBSOLETE | INSPECTIONAL OBSERVATIONS | PAGE 1of 3 PAGES |
DEPARTMENT OF HEALTH AND HUMAN SERVICES
FOOD AND DRUG ADMINISTRATION |
| DISTRICT ADDRESS AND PHONE NUMBER | DATE(S) OF INSPECTION | |
| | l/23/2019-2/13/2019* |
| 158-15 Liberty Avenue | |
| Jamaica, NY 11433 | |
| (718) 340-7000 Ext:5301 Fax:(718)662-5661 | FEI NUMBER |
| | 2433247 |
| | |
| NAME AND TITLE OF INDIVIDUALTO WHOM REPORT ISSUED |
| Eyal Mares, Vice President and General Manager Amityville Operations |
| FIRM NAME | STREET ADDRESS |
| Hi-Tech Pharmacal Co. Inc., An AKORN Company | 369 Bayview Ave |
| | |
| CTTY, STATE, ZIP CODE, COUN'TRY | TYPE ESTABLISHMENT INSPECTED |
| Amityville, NY 11701-2801 | Human Sterile and Non-Sterile Drug Manufacturer |
| The written stability testing program is not followed. |
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| Specifically, you did not perform analysis within the time frame described in your written proceduresStability Program for Pharmaceutical Drug Products,QC-093-05, effective October 8, 2018, section 10.1.1, page 14, for the following US commercial finished drug products including, but not limited to: |
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| • Cysteamine Ophthalmic Solution 0.44%, Product Code #915, Lot #360254, Start Date September 29, 2017, 12 Month Pull Date September 4, 2018, 12 Month Test Date October 10, 2018, 36 Days after Pull Date |
| • Promethazine HCl Oral Solution USP, Product Code #801A, Lot #358514, Start Date July 18, 2017, 12 Month Pull Date July 18, 2018, 12 Month Test Date September 11, 2018, 55 Days after Pull Date |
| • Clobetasol Propionate Emollient Cream 0.05%, Product Code #270, Lot #356892, Start Date May 4, 2017, 9 Month Pull Date February 2, 2018, 9 Month Test Date April 18, 2018, 75 Days after Pull Date |
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| OBSERVATION 4 |
| Containers and closures are not tested for conformance with all appropriate written procedures. |
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| Specifically, I observed that the visual inspection check and the tip & plug dimension control for the Incoming Tip and Plug Inspection Record do not adequately test or challenge the dropper tips. These tips are used as the container closure system for dorzolamide hydrochloride- and dorzolamide hydrochloride-timolol maleate ophthalmic solutions. I reviewed that there were at least 84 customer complaints in the three years prior to January 2018 for "spray/dropper malfunction" as identified by your firm's investigation PR#76724, and with at least more than 50 similar complaints from approximately January 2018 to January 2019. |
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| *DATES OF INSPECTION |
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| | EMPLOYEE(S) SIGNATURE | DATE ISSUED |
| SEE REVERSE OF THIS PAGE | Jay T Wong, Investigator |  | 2/13/2019 |
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| FORM FDA 483 (09/08) | | PREVIOUS EDITION OBSOLETE | | INSPECTIONAL OBSERVATIONS | | PAGE 2 of 3 PAGES |
| DEPARTMENT OF HEALTH AND HUMAN SERVICES |
| FOOD AND DRUG ADMINISTRATION |
| DISTRICT ADDRESS ANO PHONE NUMBER | | DATE{S) OF INSPECTION |
| | | 1/23/2019-2/13/2019* |
| 158-15 Liberty Avenue | | |
| Jamaica, NY 11433 | | FEI NUMBER |
| (718) 340-7000 Ext:5301 Fax:(718)662-5661' | | 2433247 |
| | | |
| NAME AND TITLE OF INDIVIDUAL TO WHOM REPORT ISSUED |
| Eyal Mares, Vice President and General Manager Amityville Operations |
| FIRM NAME | STREET ADDRESS |
| Hi-Tech Pharmacal Co. Inc., An AKORN Company | 369 Bayview Ave |
| | |
| CITY, STATE, ZIP CODE, COUNTRY | TYPE ESTABLISHMENT INSPECTED |
| Amityville, NY 11701-2801 | Human Sterile and Non-Sterile Drug Manufacturer |
| 1/23/2019(Wed), 1/24/2019(Thu), l/25/2019(Fri), 1/29/2019(Tue), 1/30/2019(Wed), 1/31/2019(Thu), 2/01/2019(Fri), 2/04/2019(Mon), 2/11/2019(Mon), 2/13/2019(Wed) |
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| SEE REVERSE OF THIS PAGE | EMPLOYEE(S) SIGNATURE | DATE ISSUED |
| | Jay T Wong, Investigator |  | 2/13/2019 |
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| FORM FDA 483 (09/08) | | PREVIOUS EDITION OBSOLETE | | INSPECTIONAL OBSERVATIONS | | PAGE 3 of 3 PAGES |
The observations of objectionable conditions and practices listed on the front of this form are reported:
1. Pursuant to Section 704(b) of the Federal Food, Drug and Cosmetic Act, or
2. To assist firms inspected in complying with the Acts and regulations enforced by the
Food and Drug Administration.
Section 704(b) of the Federal Food, Drug, and Cosmetic Act (21 USC 374(b)) provides:
"Upon completion of any such inspection of a factory, warehouse,consulting laboratory, or other establishment, and prior to leaving the premises, the officer or employee making the inspection shall give to the owner, operator,or agent in charge a report in writing setting forth any conditions or practices observed by him which, in his judgment, indicate that any food, drug, device,or cosmetic in such establishment (1) consists in whole or in part of any filthy, putrid, or decomposed substance, or (2) has been prepared, packed, or held under insanitary conditions whereby it may have become contaminated with filth, or whereby it may have been rendered injurious to health. A copy of suchreportshall be sent promptly to the Secretary."
