1Aseptic processing and sterility assurance
Procedures designed to prevent microbiological contamination of drug products purporting to be sterile did not include validation of the aseptic and sterilization process.
Inspection Record
Pacifico National, Inc. dba AmEx Pharmacy — FDA 483 Findings
Inspectors Brandon C Heitmeier · Susan T Hadman · Philip F IstafanosThe 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 monitoring environmental conditions.
3Laboratory and QC controls
The accuracy, sensitivity, specificity and reproducibility of test methods have not been established.
4Process validation
Time limits are not established when appropriate for the completion of each production phase to assure the quality of the drug product.
5Aseptic processing and sterility assurance
Procedures designed to prevent microbiological contamination of drug products purporiing to be sterile are not established, written and followed.
6Laboratory and QC controls
The retention period for drug product reserve samples ( except those described in 211.170 <Redacted B4> and (3)) is deficient in that they are not retained for one yeai· after the expiration date of the drug product.
7Complaint and recall handling
Procedures describing the handling of written and oral complaints related to drug products are deficiently written or followed.
8Material and supplier control
Repoo rts 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.
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.
10Training and personnel
Employees engaged in the manufacture, processing and packing of a drug product lack the education, training and experience required to perform their assigned functions.
11Stability and storage
Results of stability testing are not used in determining expiration dates.
12Labeling and packaging
Strict control is not exercised over labeling issued for use in drug product labeling operations.
About this record
Extracted automatically from the document US FDA published on 2019-07-09. 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.
