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FDA establishment 3016998516, Stanton, California, United States. Every inspection FDA has posted for the site, with its outcome and cited regulations.
Inspections: 1
Official action indicated: 0
Last inspection ended: Apr 29, 2022
Warning letters: 0
Inspections by Fiscal Year
FY2018 to FY2027 to date; 0 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 211.130. Procedures are written, and followed Procedures designed to assure that correct labels, labeling and packaging materials are used for drug products are not written.
21 CFR 211.130(c). Lot or control number assigned The drug product is not identified with a lot or control number that permits the determination of the history of the manufacture and control of the batch.
21 CFR 211.186(a). Signature and checking of records -- 2 persons The master production and control records for each batch size of drug product are not prepared, dated, and signed by one person with a full handwritten signature and independently checked, dated, and signed by a second person.
21 CFR 211.67(a). Cleaning / Sanitizing / Maintenance Equipment and utensils are not cleaned, maintained and sanitized at appropriate intervals to prevent contamination that would alter the safety, identity, strength, quality or purity of the drug product.
21 CFR 211.22(a). Lack of quality control unit There is no quality control unit.
21 CFR 211.67(c). Cleaning/maintenance records not kept Records are not kept for the maintenance, cleaning, sanitizing and inspection of equipment.
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 construction to facilitate cleaning, maintenance, and proper operations.
21 CFR 211.100(a). Absence of Written Procedures There are no written procedures for production and process controls designed to assure that the drug products have the identity, strength, quality, and purity they purport or are represented to possess.
21 CFR 211.184(d). Labeling: documentation of exam and review There is no documentation of the examination and review of labels and labeling for conformity with the assigning of a lot or control number.
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
Stanton, California, United States. Every inspection FDA has posted for the site, with its outcome and cited regulations.