1Laboratory 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.
Inspection Record
Pacific Healthcare, Inc. dba B & B Pharmacy — FDA 483 Findings
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.
3Documentation and records
Batch production and control records do not include complete information relating to the production and control of each batch.
4Contamination control
Protective apparel is not worn as necessary to protect drug products from contamination.
5Aseptic processing and sterility assurance
Procedures designed to prevent microbiological contamination of drug products purporting to be sterile are not followed.
6Aseptic processing and sterility assurance
Aseptic processing areas are deficient in that ceilings are not smooth and/or hard surfaces that are easily cleanable.
7Stability and storage
There is no written testing program designed to assess the stability characteristics of drug products.
8Equipment and facility
Washing and toilet facilities lack hot and cold water, soap or detergent, and air driers or single-service towels.
9Equipment and facility
Routine calibration of mechanical and electronic equipment is not performed according to a written program designed to assure proper performance.
10Equipment and facility
Equipment used in the manufacture, processing, packing or holding of drug products is not of appropriate design to facilitate operations for its intended use.
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.
