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FDA establishment 3015265204, Chatsworth, California, United States. Part of Chara Biologics, Inc.'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: Aug 16, 2024
Warning letters: 1
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 1271.50(a): Determination based on screening and testing1
Inspections
1 inspections, newest first
Ended
Product and area
Citations
Classification
Aug 16, 2024
Biologics · Human Cellular, Tissue, and Gene Therapies
12 cited references
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 211.100(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 211.180(b). Record maintenance 1 year (except exempt OTC) All records of control, distribution and labeling associated with a batch of drug product were not maintained at least one (1) year after the expiration date.
21 CFR 211.196. Distribution Record Requirements Distribution records do not contain the name and address of consignee and lot or control number of drug product.
21 CFR 211.134(a). Correct labels during finishing operations Packaged and labeled products are not examined during finishing operations to provide assurance that containers and packages in the lot have the correct label.
21 CFR 211.22(a). Lack of quality control unit There is no quality control unit.
21 CFR 211.125(a). Strict control not exercised over labeling issued Strict control is not exercised over labeling issued for use in drug product labeling operations.
21 CFR 1271.50(a). Determination based on screening and testing HCT/P donors were not determined to be eligible based on the results of donor screening and testing.
21 CFR 1271.370(c)(1). Name, address on label or documentation The name and address of the establishment(s) that determined that the HCT/Ps meet release criteria and made the HCT/Ps available for distribution did not appear on the HCT/P label or on documentation accompanying the HCT/P.
21 CFR 211.198(a). Procedures to be written and followed Procedures describing the handling of all written and oral complaints regarding a drug product are not established.
21 CFR 211.25(a). Training--operations, GMPs, written procedures Employees are not given training in the particular operations they perform as part of their function.
21 CFR 211.137(a). Expiration date lacking Drug products do not bear an expiration date determined by appropriate stability data to assure they meet applicable standards of identity, strength, quality and purity at the time of use.
Official Action Indicated (OAI)
Warning Letters
Letters naming this establishment; each opens the letter
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
Chatsworth, California, United States. Part of