Drug factory · FDA FEI 3014721008

ProCaire, Limited Liability Company

22 Commerce Blvd STE 5, Plainville, MA, United States

Problems found, fixed voluntarily at FDA's last inspection, May 17, 2019.

Voluntary Action Indicated: inspectors found problems, but not serious enough for FDA to take action. The company is expected to fix them.

1 drug inspection on record since 2019: 0 with no problems, 1 with problems fixed voluntarily, 0 with FDA action.

What it does, for whom

Drug	Role	For	NDC
Oxygen	Makes it	ProCaire, LLC	66694-001

Ended	Result	Program	Problems noted
May 17, 2019	Problems found, fixed voluntarily	Drug Quality Assurance	6

From FDA's Form 483 citations: conditions an investigator observed that may violate drug manufacturing rules, as FDA published them.

Labeling Control Records and Label Copies 21 CFR 211.188(b)(8)
The batch production and control records are deficient in that they do not include specimen and copy of labeling.
Procedures not in writing, fully followed 21 CFR 211.22(d)
The responsibilities and procedures applicable to the quality control unit are not in writing and fully followed.
Defined areas of adequate size for operations 21 CFR 211.42(c)
The separate or defined areas necessary to prevent contamination or mix-ups are deficient.
Cleaning / Sanitizing / Maintenance 21 CFR 211.67(a)
Equipment and utensils are not cleaned at appropriate intervals to prevent contamination that would alter the safety, identity, strength, quality or purity of the drug product.
Calibration/Inspection/Checking not done 21 CFR 211.68(a)
Routine calibration of mechanical and electronic equipment is not performed according to a written program designed to assure proper performance.
Computer control of master formula records 21 CFR 211.68(b)
Appropriate controls are not exercised over computers or related systems to assure that changes in master production and control records or other records are instituted only by authorized personnel.

Registered with FDA for: manufacture.