OSHA Inspection: MEDISCA INC.

Issued

Aug 6, 2014

Abate by

Feb 22, 2015

Penalty

Initial $7,000 · Current $5,250 Reduced

General-duty citation text

OSH ACT of 1970 Section (5)(a)(1): Section 5(a)(1) of the Occupational Safety and Health Act of 1970:  The employer did not furnish employment and a place of employment which were free from recognized hazards that were causing for likely to cause death or serious physical harm to employees in that employees were exposed to active pharmaceutical ingredients (APIs) which can cause illness, genetic defects and death:     a)  Medisca Laboratories - On or about April 16, 2014, the employer did not categorize the highly potent API to determine and provide adequate closed system containment of the powders based on the hazards and recommended exposure limits.  Employees were exposed to highly potent API while repackaging the powders by scooping the material in kilogram quantities from large containers to smaller containers via open handling method.  Accumulated API Powder was observed on the tables, floors, open face HEPA filtering systems, equipment, the employees? personal protective equipment, and on the exterior of the containers.  The highly potent API included but was not limited to:           -       Lab 2C ?Diazepam.  Hazards for Diazepam include but are not limited to, teratogen (damaging unborn child), mutagen (causing genetic defects), fatal if swallowed, contact with skin is toxic, and central nervous system depression.         -       Lab 3 ? Ketoprofen.  Hazards for Ketoprofen include but are not limited to, possible teratogen (damaging unborn child) and possible mutagen (causing genetic defects).        -       Lab 2 ? Ketamine Hydrochloride.  Hazards for Ketamine Hydrochloride include but are not limited to, possible circulatory and central nervous system damage.         -       Lab 3 ? Hydroquinone.  Hazards for Hydroquinone include but are not limited to, possible carcinogen, possible mutagen (causing genetic defects), and sensitizer.    1)  Develop and implement an active pharmaceutical powder exposure control program such as the Safebridge system, ?Occupational Health Toxicity/Potency Categorization and Handling Practices?.  The program should include but not be limited to the following:         Feasible abatement includes but is not limited to:     1)  Develop and implement an active pharmaceutical powder exposure control program such as the Safebridge system, ?Occupational Health Toxicity/Potency Categorization and Handling Practices?.  The program should include but not be limited to the following:  Evaluation of API toxicity   Evaluate acceptable occupational exposure levels.  Evaluation of occupational exposure levels should include any regulatory established levels (OSHA), non-regulatory agencies (NIOSH), non-government professional organizations (ACGIH), and API manufacturer set levels.    When there is limited or no data on occupational exposure levels for APIs, develop in-house occupational exposure limit ranges referred to as Occupational Exposure Bands (OEBs) or Control Bands.  Assigning an OEB is the assignment of a compound to a hazard category that represents a range of occupational exposures and designates the correlating safe handling methods to contain the API to include engineering controls, administrative controls, and personal protective equipment.  Several methods for setting OEBs are established in pharmaceutical focused journals.  2)  Provide localized containment and ventilation such as a vented balance safety enclosure, isolator, or bulk powder handling enclosure to adequately capture contaminant and minimize employee exposure to below acceptable occupational exposure levels.    3)  Conduct breathing zone and area air monitoring to ensure that the engineering controls contain the API to below the acceptable occupational exposure levels.   4)  Develop and implement specific procedures for the handling of APIs with the engineering controls.  5)  Train employees on methods to avoid unnecessary API exposure to include:  Donning and doffing personal protective equipment  Emergency spill mitigation techniques  Decontamination procedures  Waste handling  Product transfer in and out of containment procedures  Product transfer between container procedures  6)  Establish a medical surveillance program to evaluate potential employee exposure to API.  The program should include questionnaires, physical exams, baseline and frequent laboratory testing to determine potential exposure and symptoms.

Issued

Aug 6, 2014

Abate by

Aug 8, 2014

Penalty

Initial $3,000 · Current $2,250 Reduced

General-duty citation text

29 CFR 1910.106(e)(2)(ii)(b)(2): The quantity of Category 2, 3 or 4 flammable liquid located outside of an inside storage room or storage cabinet in a building or in any one fire area of a building exceeded 120 gallons:    a)  Chemical Storage Area - On and prior to February 10, 2014, the quantity of category 2 flammable liquids located outside of flammable storage cabinets was approximately 160 gallons in a room that did not meet the requirements of a flammable storage room.  The chemicals in storage included, but were not limited to, Isopropyl Alcohol and Ethyl Alcohol.

Issued

Aug 6, 2014

Abate by

Sep 19, 2014

Penalty

Initial $7,000 · Current $5,250 Reduced

General-duty citation text

29 CFR 1910.134(d)(1)(iii): The employer did not identify and evaluate the respiratory hazard(s) in the workplace, including a reasonable estimate of employee exposures to respiratory hazard(s) and an identification of the contaminant's chemical state and physical form:    a)  Medisca Labs - On and prior to April 16, 2014, for the repackaging of active pharmaceutical ingredients including, but not limited to, Hydroquinone (potential carcinogen), Diazepam (teratogen), Estradiol (carcinogen), Chloramphenicol (potential carcinogen), Ketoprofen (possible teratogen and possible mutagenic), and Ketamine HCL (causes central nervous system damage).  The employer failed to evaluate the respiratory hazards involved with these activities.

Issued

Aug 6, 2014

Abate by

Aug 28, 2014

Penalty

Initial $7,000 · Current $5,250 Reduced

General-duty citation text

29 CFR 1910.1200(g)(2)(iv): Each material safety data sheet (MSDS) for hazardous chemicals did not contain at least the health hazards of the hazardous chemical, including signs and symptoms of exposure, and any medical conditions which are generally recognized as being aggravated by exposure to the chemical:     a)  On and prior to April 16, 2014, the Medisca Chloramphenicol MSDS did not contain health hazards, including but not limited to, genotoxic (cause genetic defects).  This health hazard is listed on the Report on Carcinogens, Twelfth Edition of the National Toxicology Program.      b)  On and prior to April 16, 2014, the Medisca Hydroquinone MSDS did not contain health hazards, including but not limited to, mutagen (may cause genetic defects) and teratogen (may cause birth defects to a fetus).  These health hazards are listed on the original manufacturer MSDS (Bulk Medicines & Pharmaceuticals).

Issued

Aug 6, 2014

Abate by

Aug 28, 2014

Penalty

Initial $7,000 · Current $0 Reduced

General-duty citation text

29 CFR 1910.1200(g)(2)(vi): Material safety data sheets (MSDS) for hazardous chemicals did not contain at least the OSHA permissible exposure limit, ACGIH Threshold Limit Value, and any other exposure limit used or recommended by the chemical manufacturer, importer, or employer preparing the material safety data sheet:    a)  On and prior to April 16, 2014, the Medisca Diazepam MSDS did not contain an occupational exposure limit (listed as National/European) of 0.02mg/m3 listed on the original manufacturer MSDS (Cambrex Profarmaco Milano).  Hazards of Diazepam include, but are not limited to, teratogen (may cause birth defects to a fetus).    b)  On and prior to April 16, 2014, the Medisca Chloramphenicol MSDS did not contain an occupational exposure limit (listed as AIHA WEEL ) of 0.5mg/m3 listed on the original manufacturer MSDS (Yangzhou Pharmaceutical).  Hazards of Chloramphenicol include, but are not limited to, may cause cancer.    c)  On and prior to April 16, 2014, the Medisca Hydroquinone MSDS did not contain an occupational exposure limit (listed as WEL Long-term value) of 0.5mg/m3 listed on the original manufacturer MSDS (Bulk Medicines & Pharmaceuticals).  Additionally, the ACGIH TLV of 2 mg/m3, NIOSH REL 2mg/m3, NIOSH IDLH 50mg/m3 and OSHA PEL 2mg/m3 were not listed on the Medisca MSDS.  Hazards of Hydroquinone include, but are not limited to, mutagen (may cause genetic defects) and teratogen (may cause birth defects to a fetus).