1Equipment and facility
Routine calibration of mechanical and electronic equipment is not performed according to a wrillcn program designed to assure proper performance.
Inspection Record
Pacific Healthcare, Inc. dba B & B Pharmacy — FDA 483 Findings
Inspectors I'. Nguyen · Binh T. Nguyen · Yasamin AmeriThe inspectors who signed the published document.Inspector lookup
View the regulator's official source The source document is always the basis for judgement.
Findings
2Equipment and facility
Washing and toilet faci lities lack hot and cold water.
3Aseptic processing and sterility assurance
Procedures designed to prevent microbiological contamination ofdrug products purporting to be sterile arc not followed.
4Aseptic processing and sterility assurance
Aseptic process ing areas are deficient regarding the system for monitoring environmental cond itions.
5Documentation and records
Batch production and control records do not include complete information relating to the production and control of each bat ch specifically, t he f irm d oes n ot r equire co mplete in formation to be rec orded on for mula wor ksheets.
6Aseptic processing and sterility assurance
As e ptic processing areas are deficient regarding the system for cleaning and disinfecting the room and equipment to produce ase ptic conditions.
7Contamination control
Protective apparel i s not worn as necessary to protect drug products from contamination.
8Stability and storage
Thtre is no written testing program designed to assess the stabi lity characteristics or drug products.
9Aseptic processing and sterility assurance
Asept ic processing areas are deficient in that ceilings are not smooth and/or hard surfaces that are easily c leanable.
10Laboratory and QC controls
T esting and release ofdrug product for distr ibution do not include appropriate laboratory determinat ion ofsat isfactory confonne1 nce to th e tinal specifications prior to release.
11Equipment and facility
Equipment used in the manufacture, processing, packing or holding ofdrug products is not ofappropriate design to facilitate opemtions 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.
