Drug factory · FDA FEI 3002807504

Merck Sante

2 rue du Pressoir Vert, Semoy, France

Problems found, fixed voluntarily at FDA's last inspection, Oct 25, 2024.

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

4 drug inspections on record since 2013: 1 with no problems, 3 with problems fixed voluntarily, 0 with FDA action.

What it does, for whom

Drug	Role	For	NDC
Hydroxocobalamin	Makes it, tests it, packages it and labels it	BTG International Inc.	50633-310

Ended	Result	Program	Problems noted
Oct 25, 2024	Problems found, fixed voluntarily	Drug Quality Assurance	—
Jun 14, 2018	No problems found	Drug Quality Assurance	—
Jun 21, 2016	Problems found, fixed voluntarily	Drug Quality Assurance	3
Jun 17, 2013	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.

Scientifically sound laboratory controls 21 CFR 211.160(b)
Laboratory controls do not include the establishment of scientifically sound and appropriate sampling plans and test procedures designed to assure that drug products conform to appropriate standards of identity, strength, quality and purity.
Instruments, apparatus, et. al. not meeting specs 21 CFR 211.160(b)(4)
The use of apparatus not meeting established specifications was observed.
Cleaning / Sanitizing / Maintenance 21 CFR 211.67(a)
Equipment and utensils are not cleaned and maintained at appropriate intervals to prevent malfunctions and contamination that would alter the safety, identity, strength, quality or purity of the drug product.

Extent of discrepancy, failure investigations 21 CFR 211.192
Investigations of a failure of a batch or any of its components to meet any of its specifications did not extend to other drug products that may have been associated with the specific failure or discrepancy.
Written record of investigation incomplete 21 CFR 211.192
Written records of investigations into unexplained discrepancies and the failure of a batch or any of its components to meet specifications do not always include the conclusions and follow-up.
Approve or reject procedures or specs 21 CFR 211.22(c)
The quality control unit lacks responsibility to approve and reject all procedures or specifications impacting on the identity, strength, quality, and purity of drug products.
Written procedures fail to include 21 CFR 211.67(b)
Written procedures for cleaning and maintenance fail to include parameters relevant to the operation.
Contamination, chemical or physical change, deterioration 21 CFR 314.81(b)(1)(ii)
An NDA-Field Alert Report was not submitted within three working days of receipt of information concerning significant chemical, physical, or other change or deterioration in a distributed drug product.

Registered with FDA for: analysis; label; manufacture; pack; sterilize.