OSHA Inspection: QUVA PHARMA, INC

Issued

Dec 23, 2024

Penalty

Initial $11,524 · Current $11,524

Hazardous substances 1470

General-duty citation text

29 CFR  1910.134(c)(1): A written respiratory protection program that included the provisions in 29 CFR 1910.134(c)(1)(i) - (ix) with worksite specific procedures was not established and implemented for required respirator use:  (a) QuVa Pharma, Inc 519 State Route 173 Bloomsbury, NJ 08804 prep room in Building 1 and 2  On or about June 27, 2024, and thereafter, employee(s) were provided and required to use Alpha ProTech N-95 Particulate Respirator during the wiping process of medical equipment such as Syringes and IV bags using STERI-PEROX wipes containing 6% hydrogen peroxide as part of their daily duties, for which the employer did not have a written program for administering the use of respiratory protection in the workplace. Employee(s) were exposed to health hazard(s), including inhalation of toxic/hazardous substances such as hydrogen peroxide, as well as cardio-respiratory impacts from using a tight-fitting, negative-pressure respirator.

Issued

Dec 23, 2024

Penalty

Initial $0 · Current $0

Hazardous substances 1470

General-duty citation text

29 CFR  1910.134(e)(1): The employer did not provide a medical evaluation to determine the employee's ability to use a respirator, before the employee was fit tested or required to use the respirator in the workplace:  (a) QuVa Pharma, Inc 519 State Route 173 Bloomsbury, NJ 08804 prep room in Building 1 and 2  On or about June 27, 2024, and thereafter, employee(s) were provided and required to use Alpha ProTech N-95 Particulate Respirator during the process of wiping of medical equipment such as Syringes and IV bags using STERI-PEROX 6% wipes containing 6% hydrogen peroxide as part of their daily duties for which the employer did not provide a medical evaluation for employees to determine their ability to use a respirator before requiring use.  Employee(s) were exposed to health hazard(s), including inhalation of toxic / hazardous substances such as hydrogen peroxide, as well as cardio-respiratory impacts from using a tight-fitting, negative-pressure respirator.

Issued

Dec 23, 2024

Penalty

Initial $0 · Current $0

Hazardous substances 1470

General-duty citation text

29 CFR  1910.134(k): The employer did not provide comprehensive, understandable training annually or more often if necessary:  (a) QuVa Pharma, Inc 519 State Route 173 Bloomsbury, NJ 08804 prep room in Building 1 and 2  On or about June 27, 2024, and thereafter, employee(s) were provided and required to use Alpha ProTech N-95 Particulate Respirator during the process of wiping medical equipment such as Syringes and IV bags using STERI-PEROX wipes containing 6% hydrogen peroxide as part of their daily duties, for which the employer did not provide training on respirator inspection, use (including seal-check), maintenance and storage.  OSHA conducted personal exposure monitoring for airborne hydrogen peroxide vapor on August 5, 2024, during manual wiping of medical equipment as part of normal daily activities for two employees in Building 1 and two employees in Building 2.   In Building 1, during 337 minutes of sampling and 358 minutes of sampling, with zero exposure assumed for the balance of the 480-min work shift, their exposures were measured at 3.19 parts per million (ppm) and 2.19 ppm, respectively, as an 8-hour time-weighted average (TWA).   These measured exposures represent 319 % and 219 % of the OSHA Permissible Exposure Limit (PEL) of 1 ppm as an 8-hour TWA, exposing employees to health hazard(s) of airborne hydrogen peroxide vapor.  In Building 2, during 293 minutes of sampling and 216 minutes of sampling, with zero exposure assumed for the balance of the 480-min work shift, their exposures were measured at 7.22 parts per million (ppm) and 1.89 ppm, respectively, as an 8-hour time-weighted average (TWA).   These measured exposures represent 722 % and 189 % of the OSHA Permissible Exposure Limit (PEL) of 1 ppm as an 8-hour TWA, exposing employees to health hazard(s) of airborne hydrogen peroxide vapor.

Issued

Dec 23, 2024

Penalty

Initial $13,828 · Current $13,828

Hazardous substances 1470

General-duty citation text

29 CFR  1910.134(d)(3)(ii): The employer did not provide a respirator that was appropriate for the chemical state and physical form of the contaminant:   (a) QuVa Pharma, Inc 519 State Route 173 Bloomsbury, NJ 08804 prep room in Building 1 and 2  On or about June 27, 2024, and thereafter, employee(s) were provided and required to AlphaProTech N-95 Particulate Respirator during the wiping process of medical equipment such as Syringes and IV bags using STERI-PEROX 6% wipes containing 6% hydrogen peroxide as part of their daily duties which is not the appropriate respirator for the chemical and physical form of the contaminant.    Note: The NIOSH Pocket Guide to Chemical Hazards recommends a supplied air respirator (APF=10) for hydrogen peroxide exposure (up to 10 parts per million (ppm)).   OSHA conducted personal exposure monitoring for airborne hydrogen peroxide vapor on August 5, 2024, during manual wiping of medical equipment as part of normal daily activities for two employees in Building 1 and two employees in Building 2.   In Building 1, during 337 minutes of sampling and 358 minutes of sampling, with zero exposure assumed for the balance of the 480-min work shift, their exposures were measured at 3.19 parts per million (ppm) and 2.19 ppm, respectively, as an 8-hour time-weighted average (TWA).   These measured exposures represent 319 % and 219 % of the OSHA Permissible Exposure Limit (PEL) of 1 ppm as an 8-hour TWA, exposing employees to health hazard(s) of airborne hydrogen peroxide vapor.  In Building 2, during 293 minutes of sampling and 216 minutes of sampling, with zero exposure assumed for the balance of the 480-min work shift, their exposures were measured at 7.22 parts per million (ppm) and 1.89 ppm, respectively, as an 8-hour time-weighted average (TWA).   These measured exposures represent 722 % and 189 % of the OSHA Permissible Exposure Limit (PEL) of 1 ppm as an 8-hour TWA, exposing employees to health hazard(s) of airborne hydrogen peroxide vapor.

Issued

Dec 23, 2024

Penalty

Initial $138,273 · Current $42,148 Reduced

Hazardous substances 1470

General-duty citation text

29 CFR  1910.1000(a)(2): Employee(s) were exposed to an airborne concentration of hydrogen peroxide listed in Table Z-1 in excess of the 8-hour Time Weighted Average concentration of 1 ppm:  (a) QuVa Pharma, Inc 519 State Route 173 Bloomsbury, NJ 08804 prep room in Building 1 and 2  On or about June 27, 2024, and thereafter, employee(s) using STERI-PEROX wipes containing 6% hydrogen peroxide to wipe down medical equipment, such as Syringes and IV bags as part of their daily duties, were exposed to an airborne concentration of hydrogen peroxide in excess of the 8-hour Time Weighted Average concentration of 1 ppm.  OSHA conducted personal exposure monitoring for airborne hydrogen peroxide vapor on August 5, 2024, during manual wiping of medical equipment as part of normal daily activities for two employees in Building 1 and two employees in Building 2.   In Building 1, during 337 minutes of sampling and 358 minutes of sampling, with zero exposure assumed for the balance of the 480-min work shift, their exposures were measured at 3.19 parts per million (ppm) and 2.19 ppm, respectively, as an 8-hour time-weighted average (TWA).   These measured exposures represent 319 % and 219 % of the OSHA Permissible Exposure Limit (PEL) of 1 ppm as an 8-hour TWA, exposing employees to health hazard(s) of airborne hydrogen peroxide vapor.  In Building 2, during 293 minutes of sampling and 216 minutes of sampling, with zero exposure assumed for the balance of the 480-min work shift, their exposures were measured at 7.22 parts per million (ppm) and 1.89 ppm, respectively, as an 8-hour time-weighted average (TWA).   These measured exposures represent 722 % and 189 % of the OSHA Permissible Exposure Limit (PEL) of 1 ppm as an 8-hour TWA, exposing employees to health hazard(s) of airborne hydrogen peroxide vapor.

Issued

Dec 23, 2024

Penalty

Initial $0 · Current $0

Hazardous substances 1470

General-duty citation text

29 CFR  1910.1000(e): Feasible administrative or engineering controls were not determined and implemented to achieve compliance with the limits prescribed in 29 CFR 1910.1000(a) through (d):  (a) QuVa Pharma, Inc 519 State Route 173 Bloomsbury, NJ 08804 prep room in Building 1 and 2  On or about June 27, 2024, and thereafter, employee(s) used STERI-PEROX wipes containing 6% hydrogen peroxide to wipe down medical equipment, such as Syringes and IV bags as part of their daily duties, in prep room where feasible administrative or engineering controls were not determined and implemented to achieve compliance with the limits prescribed in 29 CFR 1910.1000(a) through (d). This exposed employees to an airborne concentration of hydrogen peroxide above the 8-hour Time Weighted Average concentration of 1 ppm.  OSHA conducted personal exposure monitoring for airborne hydrogen peroxide vapor on August 5, 2024, during manual wiping of medical equipment as part of normal daily activities for two employees in Building 1 and two employees in Building 2.   In Building 1, during 337 minutes of sampling and 358 minutes of sampling, with zero exposure assumed for the balance of the 480-min work shift, their exposures were measured at 3.19 parts per million (ppm) and 2.19 ppm, respectively, as an 8-hour time-weighted average (TWA).   These measured exposures represent 319 % and 219 % of the OSHA Permissible Exposure Limit (PEL) of 1 ppm as an 8-hour TWA, exposing employees to health hazard(s) of airborne hydrogen peroxide vapor.  In Building 2, during 293 minutes of sampling and 216 minutes of sampling, with zero exposure assumed for the balance of the 480-min work shift, their exposures were measured at 7.22 parts per million (ppm) and 1.89 ppm, respectively, as an 8-hour time-weighted average (TWA).   These measured exposures represent 722 % and 189 % of the OSHA Permissible Exposure Limit (PEL) of 1 ppm as an 8-hour TWA, exposing employees to health hazard(s) of airborne hydrogen peroxide vapor.