OSHA Inspection: ADARE PHARMA SOLUTIONS DBA ADARE PHARMACEUTICALS, INC.

Issued

Sep 27, 2024

Abate by

Nov 15, 2024

Penalty

Initial $16,131 · Current $8,066 Reduced

General-duty citation text

29 CFR 1910.132(d)(1): The employer shall assess the workplace to determine if hazards are present, or are likely to be present, which necessitate the use of personal protective equipment (PPE). If such hazards are present, or likely to be present, the employer shall: (i) Select, and have each affected employee use, the types of PPE that will protect the affected employee from the hazards identified in the hazard assessment; (ii) Communicate selection decisions to each affected employee; and,  a) On or about April 30, 2024, the employer did not ensure that employees used the PPE listed in the hazard assessment placed on the batch record for cyclobenzaprine in that employees were not wearing Tyvek suits and sleeve guards when weighing and dispensing cyclobenzaprine, exposing employees to cyclobenzaprine contaminants left on their work uniforms.  b) On or about April 30, 2024, the employer did not complete a workplace hazard assessment for employees who changed the prefilters on the Walker 3.5M Pharmair downflow dry chemical dispensing booth, exposing the employees to valbenazine (angioedema), cyclobenzaprine (tachycardia), and potassium chloride (heart attack) without personal protective equipment including but not limited to face shields and coverings, safety glasses, Tyvek suits, and protective gloves.

Issued

Sep 27, 2024

Abate by

Nov 15, 2024

Penalty

Initial $0 · Current $0

General-duty citation text

29 CFR 1910.132(f)(1)(iii): The employer shall provide training to each employee who is required by this section to use PPE. Each such employee shall be trained to know at least the following: How to properly don, doff, adjust, and wear PPE;  a) On or about April 30, 2024, the employer had not provided training to employees on how to properly remove personal protective equipment such as gloves, shoes, and disposable frock without exposing themselves to contaminants on the outside of the PPE such as but not limited to cyclobenzaprine.

Issued

Sep 27, 2024

Abate by

Nov 15, 2024

Penalty

Initial $16,131 · Current $8,066 Reduced

General-duty citation text

29 CFR 1910.134(c)(1): In any workplace where respirators are necessary to protect the health of the employee or whenever respirators are required by the employer, the employer shall establish and implement a written respiratory protection program with worksite-specific procedures. The program shall be updated as necessary to reflect those changes in workplace conditions that affect respirator use. The employer shall include in the program the following provisions of this section, as applicable: (i) Procedures for selecting respirators for use in the workplace; (vii) Training of employees in the respiratory hazards to which they are potentially exposed during routine and emergency situations; (viii) Training of employees in the proper use of respirators, including putting on and removing them, any limitations on their use, and their maintenance; and  a) On or about April 18, 2024, the employer did not establish and implement the elements of a written respiratory protection program to ensure that employees were provided with and wore adequate respiratory protection to protect them from inhalation exposure to chemicals, such as but not limited to, cyclobenzaprine and valbenazine while mixing and dispensing.

Issued

Sep 27, 2024

Abate by

Nov 15, 2024

Penalty

Initial $0 · Current $0

General-duty citation text

29 CFR  1910.134(g)(2)(i): Use of respirators. This paragraph requires employers to establish and implement procedures for the proper use of respirators. These requirements include prohibiting conditions that may result in facepiece seal leakage, preventing employees from removing respirators in hazardous environments, taking actions to ensure continued effective respirator operation throughout the work shift, and establishing procedures for the use of respirators in IDLH atmospheres or in interior structural firefighting situations. Continuing respirator effectiveness. Appropriate surveillance shall be maintained of work area conditions and degree of employee exposure or stress. When there is a change in work area conditions or degree of employee exposure or stress that may affect respirator effectiveness, the employer shall reevaluate the continued effectiveness of the respirator.  a) On or about April 30, 2024, surveillance was not maintained of work area conditions and the degree of employee exposure to chemicals including but not limited to cyclobenzaprine in that the employer failed to ensure that employees were always wearing a respirator when dispensing dry chemicals in the Walker Pharmair downflow ventilation booth, as required by the batch record.

Issued

Sep 27, 2024

Abate by

Nov 15, 2024

Penalty

Initial $0 · Current $0

General-duty citation text

29 CFR 1910.134(k)(1): Training and information. This paragraph requires the employer to provide effective training to employees who are required to use respirators. The training must be comprehensive, understandable, and recur annually, and more often if necessary. This paragraph also requires the employer to provide the basic information on respirators in Appendix D of this section to employees who wear respirators when not required by this section or by the employer to do so. The employer shall ensure that each employee can demonstrate knowledge of at least the following:  (i) Why the respirator is necessary and how improper fit, usage, or maintenance can compromise the protective effect of the respirator; (iv) How to inspect, put on and remove, use, and check the seals of the respirator;  a) On or about April 30, 2024, the employer did not provide effective training on why respirators are necessary in that employees were not wearing respiratory protection when dispensing and weighing chemicals including but not limited to cyclobenzaprine.

Issued

Sep 27, 2024

Abate by

Nov 15, 2024

Penalty

Initial $0 · Current $0

General-duty citation text

29 CFR 1910.134(l)(2)(ii): Program evaluation. This section requires the employer to conduct evaluations of the workplace to ensure that the written respiratory protection program is being properly implemented, and to consult employees to ensure that they are using the respirators properly. The employer shall regularly consult employees required to use respirators to assess the employees' views on program effectiveness and to identify any problems. Any problems that are identified during this assessment shall be corrected. Factors to be assessed include, but are not limited to: Appropriate respirator selection for the hazards to which the employee is exposed;  a) On or about April 30, 2024, the employer had not evaluated their respiratory protection program to ensure that employees were wearing the proper respiratory protection, as required by the batch records in that a powered air purifying respirator or half-mask respirator with P100 or HEPA filters were not worn when dispensing and weighing pharmaceuticals such as cyclobenzaprine.