1Aseptic processing and sterility assurance
Aseptic processing areas are deficient regarding systems for maintaining any equipment used to control the aseptic conditions.
Inspection Record
Empower Clinic Services LLC dba Empower Pharmacy — FDA 483 Findings
Inspectors Suzanne N VallezThe inspectors who signed the published document.Inspector lookup
View the regulator's official source The source document is always the basis for judgement.
Findings
2Aseptic processing and sterility assurance
Aseptic processing areas are deficient regarding the system for cleaning and disinfecting the room and equipment to produce aseptic conditions.
3Other quality system
Adverse drug experience information has not been reported to FDA.
4Aseptic processing and sterility assurance
Procedures designed to prevent microbiological contamination of drug products purporting to be sterile are not established, written and followed.
5Material and supplier control
Written procedures are lacking which describe in sufficient detail the receipt, handling, sampling, testing, approval and rejection of components.
6Regulatory reporting and change control
Bulk drug substances used by your outsourcing facility to compound drug products are not each manufactured by an establishment that is registered under section 510 as required by section 503B(a)(2)(C).
7Labeling and packaging
The labels of your outsourcing facility's drug products are deficient.
8Quality unit oversight
Written procedures are not established and followed for evaluations conducted at least annually to review records associated with a representative number of batches, whether approved or rejected.
9Aseptic processing and sterility assurance
Drug product containers and closures were not clean and sterilized and processed to remove pyrogenic properties to assure that they are suitable for their intended use.
10Laboratory and QC controls
Laboratory controls do not include the establishment of scientifically sound and appropriate specifications, standards and test procedures designed to assure that components and drug products conform to appropriate standards of identity, strength, quality and purity.
11Aseptic processing and sterility assurance
Procedures designed to prevent microbiological contamination of drug products purporting to be sterile did not include adequate validation of the aseptic process.
12Process validation
Written procedures are not established and followed that describe the in-process controls, tests and examinations to be conducted on appropriate samples of in-process materials of each batch.
13Deviation, 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.
14Quality unit oversight
The responsibilities and procedures applicable to the quality control unit are not in writing and fully followed.
15Regulatory reporting and change control
Your outsourcing facility did not submit a report to FDA identifying the drugs compounded during the previous six month period.
About this record
Extracted automatically from the document US FDA published on 2022-10-11. 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.
