Drug factory · FDA FEI 2450054

Perrigo New York, Inc.

1700 Bathgate Ave, Bronx, NY, United States

Problems found, fixed voluntarily at FDA's last inspection, May 8, 2026.

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

8 drug inspections on record since 2009: 4 with no problems, 4 with problems fixed voluntarily, 0 with FDA action.

What it does, for whom

Drug	Role	For	NDC
Desonide	Makes it	Encore Dermatology Inc.	69482-600

Ended	Result	Program	Problems noted
May 8, 2026	Problems found, fixed voluntarily	Drug Quality Assurance	4
Sep 17, 2024	Problems found, fixed voluntarily	Drug Quality Assurance	—
Jan 22, 2019	Problems found, fixed voluntarily	Drug Quality Assurance	2
Mar 8, 2017	Problems found, fixed voluntarily	Drug Quality Assurance	2
Apr 22, 2015	No problems found	Drug Quality Assurance	—
May 28, 2013	No problems found	Drug Quality Assurance	—
Apr 13, 2012	No problems found	Drug Quality Assurance	—
Oct 28, 2009	No problems found	Drug Quality Assurance	—

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

Mfg / Processing Operations Area 21 CFR 211.42(c)(5)
Separate or defined areas to prevent contamination or mix-ups are deficient regarding the manufacturing and processing operations.
Equipment for Environmental Control 21 CFR 211.46(b)
Equipment for adequate control over air pressure is not provided when appropriate for the manufacture, processing, packing or holding of a drug product.
Buildings not maintained in good state of repair 21 CFR 211.58
Buildings used in the manufacturing of a drug product are not maintained in a good state of repair.
Cleaning / Sanitizing / Maintenance 21 CFR 211.67(a)
Equipment and utensils are not maintained at appropriate intervals to prevent contamination that would alter the safety, identity, strength, quality or purity of the drug product.

Investigations of discrepancies, failures 21 CFR 211.192
There is a failure to thoroughly review the failure of a batch or any of its components to meet any of its specifications whether or not the batch has been already distributed.
Written procedures fail to include 21 CFR 211.67(b)
Written procedures for cleaning and maintenance fail to include description in sufficient detail of methods, equipment and materials used.

Storage under appropriate conditions 21 CFR 211.142(b)
Drug products are not stored under appropriate conditions of temperature so that their identity, strength, quality, and purity are not affected.
Written procedures fail to include 21 CFR 211.67(b)
Written procedures for cleaning and maintenance fail to include description in sufficient detail of methods, equipment and materials used.

Registered with FDA for: label; manufacture; pack.