1Aseptic processing and sterility assurance
Aseptic processing areas are deficient regarding temperature and humidity controls.
Inspection Record
The Compounding Pharmacy of America — FDA 483 Findings
Inspectors Zada L. Giles · Marvin D. JonesThe 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 air supply that is filtered through high-efficiency particulate air filters under positive pressure.
3Material and supplier control
Reports of analysis from component suppliers are accepted in lieu of testing each component for conformity with all appropriate written specifications, without performing at least one specific identity test on each component and establishing the reliability of the supplier's analyses through appropriate validation of the supplier's test results at appropriate intervals.
4Aseptic 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.
5Equipment and facility
Routine calibration of equipment is not performed according to a written program designed to assure proper performance.
6Aseptic processing and sterility assurance
Procedures designed to prevent microbiological contamination of drug products purporting to be sterile are not established and followed.
7Aseptic processing and sterility assurance
Separate or defined areas to prevent contamination or mix-ups are deficient regarding operations related to aseptic processing of drug products.
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
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.
10Documentation and records
Batch production and control records do not include complete information relating to the production and control of each batch.
11Aseptic processing and sterility assurance
Aseptic processing areas are deficient regarding the system for monitoring environmental conditions.
12Process validation
Time limits are not established when appropriate for the completion of each production phase to assure the quality of the drug product.
13Aseptic processing and sterility assurance
Aseptic processing areas are deficient regarding the system for cleaning and disinfecting the room and equipment to produce aseptic conditions.
14Training and personnel
Clothing of personnel engaged in the manufacturing, processing, and packing of drug products is not appropriate for the duties they perform.
15Stability and storage
Results of stability testing are not used in determining expiration dates.
16Quality unit oversight
There is no quality control unit.
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.
