Drug factory · FDA FEI 3005138167

Maco Productions

200 CHS Fernand Forest, Tourcoing, France

Problems found, fixed voluntarily at FDA's last inspection, Sep 12, 2017.

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 2017: 0 with no problems, 1 with problems fixed voluntarily, 0 with FDA action.

What it does, for whom

Drug	Role	For	NDC
Anticoagulant Citrate Phosphate Dextrose (cpd) Solution and Adsol Preservation S	Makes it	Maco Productions	14498-001, 14498-002

Ended	Result	Program	Problems noted
Sep 12, 2017	Problems found, fixed voluntarily	Drug Quality Assurance	5

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

Adequate number of batches on stability 21 CFR 211.166(b)
An adequate number of batches of each drug product are not tested nor are records of such data maintained to determine an appropriate expiration date.
Procedures not in writing, fully followed 21 CFR 211.22(d)
The responsibilities and procedures applicable to the quality control unit are not fully followed.
Sanitation--buildings not clean, free of infestation 21 CFR 211.56(a)
Buildings used in the manufacture, processing, packing or holding of drug products are not maintained in a clean and sanitary condition.
Buildings not maintained in good state of repair 21 CFR 211.58
Buildings used in the manufacturing, processing and packing of a drug product are not maintained in a good state of repair.
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.