1Aseptic processing and sterility assurance
Aseptic processing areas are deficient regarding the system for monitoring environmental conditions.
Inspection Record
Fagron Compounding Service LLC dba Fagron Sterile Services — FDA 483 Findings
Inspectors Erika V ButlerThe inspectors who signed the published document.Inspector lookup
View the regulator's official source The source document is always the basis for judgement.
Findings
2Labeling and packaging
Packaged and labeled products are not examined during finishing operations to provide assurance that containers and packages in the lot have the corrected label.
3Other quality system
Adverse drug event information has not been reported to FDA.
4Contamination control
Protective apparel is not worn as necessary to protect drug products from contamination.
5Quality unit oversight
The responsibilities and procedures applicable to the quality control unit are not fully followed.
6Other quality system
Your firm compounded drugs that are essentially a copy of one or more approved drugs within the meaning of sections 503B(a)(5) and 503B(d)(2).
7Deviation, CAPA, and investigation
There is a failure to thoroughly review any unexplained discrepancy and 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.
8Laboratory and QC controls
Testing and release of drug product for distribution do not include appropriate laboratory determination of satisfactory conformance to the final specifications prior to release.
9Regulatory reporting and change control
Bulk drug substances used by your outsourcing facility to compound drug products are not each manufactured by an establishment that lS registered under section 510 as required by section 503B(a)(2)(C).
10Labeling and packaging
The labels of your outsourcing facility's drug products do not include information required by section 503B(a)(l 0)(A).
11Equipment and facility
Equipment and utensils are not cleaned and maintained at appropriate intervals to prevent that would alter the safety, identity, strength, quality or purity of the drng product.
About this record
Extracted automatically from the document US FDA published on 2019-09-16. The source is available at the link above.
This is a record of that moment. Inspection findings are usually followed by the company's response and corrective action, but this page does not know how that turned out. Do not read it as the current state; check the regulator's official announcements for the latest status.
Translation and classification are automated and may differ in nuance from the source.
