1Aseptic processing and sterility assurance
Aseptic processing areas are deficient regarding the system for monitoring environmental conditions.
Inspection Record
Apothecure, Inc. — FDA 483 Findings
Inspectors Stephen D. BrownThe inspectors who signed the published document.Inspector lookup
View the regulator's official source The source document is always the basis for judgement.
Findings
2Other quality system
Filled drug product containers which are set aside and held in an unlabeled condition are not identified to preclude mislabeling of individual containers, lots or portions of lots.
3Contamination control
Protective apparel is not worn as necessary to protect drug products from contamination.
4Aseptic processing and sterility assurance
Procedures designed to prevent microbiological contamination ofdrug products purporting to be sterile are not established, written, and followed.
5Equipment and facility
Equipment and utensils are not c1eaned and maintained at appropriate intervals to prevent contamination that would alter the safety, identity, strength, quality or purity ofthe drug product.
6Laboratory and QC controls
Each batch of drug product required to be free of objectionable microorganisms is not tested through appropriate laboratory testing.
7Process validation
There are no written procedures for production and process controls designed to assure that the drug products have the identity, strength.
8Material and supplier control
There is a failure to thoroughly review 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.
9Aseptic processing and sterility assurance
Aseptic processing areas are deficient regarding the system for cleaning and disinfecting the room and equipment to produce aseptic conditions.
10Laboratory and QC controls
Testing and release of drug product for distrbution do not include appropriate laboratory determination of satisfactory conformance to the identity and strength of each active ingredient prior to release.
11Documentation and records
Master production and control records lack complete manufacturing and control instructions and specifications.
12Stability and storage
There is no written testing program designed to assess the stability characteristics of drug products.
13Complaint and recall handling
Procedures describing the handling ofall written and oral complaints regarding a drug product are not followed.
About this record
Extracted automatically from the document US FDA published on 2024-01-17. 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.
