1Aseptic processing and sterility assurance
Aseptic processing areas are deficient regarding the system for cleaning and disinfecting the room and equipment to produce aseptic conditions.
Inspection Record
Meditech Laboratories, Inc. — FDA 483 Findings
Inspectors David Eng · Dustin P Tran · Eileen A LiuThe inspectors who signed the published document.Inspector lookup
View the regulator's official source The source document is always the basis for judgement.
Findings
2Quality unit oversight
Drug product production and control records, are not approved by the quality control unit to determine compliance with all established, approved written procedures before a batch is released or distributed.
3Deviation, 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.
4Contamination control
Container closure systems do not provide adequate protection against foreseeable external factors in storage and use that can cause deterioration or contamination of the drug product.
5Quality unit oversight
The responsibilities and procedures applicable to the quality control unit are not in writing.
6Aseptic processing and sterility assurance
Specifically, according to your firm’s “Sterile compounding standards operating procedures”, updated 10/10/2015, under REDACTED B4”, a REDACTED B4.
7Stability and storage
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.
8Aseptic 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.
9Aseptic processing and sterility assurance
Aseptic processing areas are deficient regarding air supply that is filtered through high-efficiency particulate air filters under positive pressure.
10Laboratory 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.
11Aseptic processing and sterility assurance
Aseptic processing areas are deficient regarding the system for monitoring environmental conditions.
12Aseptic processing and sterility assurance
Each batch of drug product purporting to be sterile and pyrogen-free is not laboratory tested to determine conformance to such requirements.
13Contamination control
Protective apparel is not worn as necessary to protect drug products from contamination.
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.
