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FDA establishment 3042030663, Dayton, New Jersey, United States. Part of Safrel Pharmaceuticals LLC's FDA records. Every inspection FDA has posted for the site, with its outcome and cited regulations.
Inspections: 1
Official action indicated: 1
Last inspection ended: Jan 30, 2026
Warning letters: 0
Inspections by Fiscal Year
FY2018 to FY2027 to date; 1 classified OAI
How to read this
A hatched bar is a year that is not over, so its count covers only part of the year.
21 CFR 211.100(a). Absence of Written Procedures Your firm failed to establish written procedures for production and process controls designed to assure that the drug products have the identity, strength, purity, and quality that they are purported or represented to possess.
21 CFR 211.150(b). Distribution Recall System The distribution system is deficient in that each lot of drug product cannot be readily determined to facilitate its recall if necessary.
21 CFR 111.535(b). Make and keep records - returned dietary supplements You did not make and keep records for your returned dietary supplement operations.
21 CFR 211.180(c). Records not made readily available to FDA Records associated with drug product components, containers, closures, labeling, control and distribution and within the retention period for such records, were not made readily available for authorized inspection.
21 CFR 111.553. Written procedures - establish; product complaint You did not establish written procedures for the requirements to review and investigate a product complaint.
21 CFR 111.103. Written procedures - establish; quality control operations You did not establish written procedures for quality control operations.
21 CFR 111.455(a). Hold - temperature, humidity, light You did not hold dietary supplements under appropriate conditions of temperature, humidity, or light so that their identity, purity, strength, and composition are not affected.
21 CFR 211.22(a). Lack of quality control unit There is no quality control unit.
21 CFR 111.475(b). Records - written procedures holding and distribution; product distribution You did not make and keep records for written procedures for holding and distributing operations and product distribution.
21 CFR 211.42(a). Buildings of Suitable Size, Construction, Location Buildings used in the manufacture, processing, packing, or holding of a drug product do not have the suitable to facilitate cleaning, maintenance, and proper operations.
An FEI (FDA Establishment Identifier) names one physical site. Inspections, outcomes and citations come from FDA's Data Dashboard; FDA posts citations only for some inspections. A contract site can make products for many companies, so the company shown is the one FDA lists as the site's firm.FDA Data Dashboard and warning letters
Dayton, New Jersey, United States. Part of