1Equipment and facility
Equipment and utensils are not cleaned and sanitized at appropriate intervals to prevent contamination that would alter the safety, identity, strength, quality or purity of the drug product.
Inspection Record
Reed Pharmacy, Inc. — FDA 483 Findings
Inspectors Robert J HamThe inspectors who signed the published document.Inspector lookup
View the regulator's official source The source document is always the basis for judgement.
Findings
2Laboratory and QC controls
Testing and release of drug products for distribution do not include appropriate laboratory determination of satisfactory conforfuance to the final specifications and identity and strength of each active ingredient prior to release.
3Documentation and records
The batch production and control records are deficient in that they do not include documentation of the accomplishment of each significant step in manufacturing.
4Other quality system
Your firm released drug product in which the strength differs from, or its purity or quality falls below, that which it purports or is represented to possess.
5Stability and storage
Drug products do not bear an expiration date determined by appropriate stability data to assure they meet applicable identfiy, strength, quality, and purity at the time of use.
About this record
Extracted automatically from the document US FDA published on 2019-04-30. 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.
