1Documentation 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 processing .
Inspection Record
Beacon Hill Medical Pharmacy,P.C. — FDA 483 Findings
Inspectors Sarah M. NapierThe inspectors who signed the published document.Inspector lookup
View the regulator's official source The source document is always the basis for judgement.
Findings
2Process validation
There are no written procedures for production and process controls designed to assure that tbe drug products have the identity, strength, quality~ and purity they purport or are represented to possess.
3Other quality system
The responsibilities and procedures applicable to the quality controlilllit are not in writing and fully followed.
4Quality unit oversight
Each lot of components, drug product containers, and closures is not withheld from use until the lot has been sampled, tested, examined, and released by the quality control unit.
5Laboratory and QC controls
Testing and release of drug product for distribution do not include appropriate laboratory determination of satisfactory conformance to the identity and strength of each active ingredient prior to release.
6Quality unit oversight
The establishment of specifications, sampling plans, test procedures, and laboratory control mechanisms including an y changes thereto, are not drafted by the appropriate organizational unit and reviewed and approved by the quality control unit.
7Aseptic processing and sterility assurance
Drug product containers and closures were not sterilized and processed to remove pyrogenic properties to assure that they are suitab le for their intended use.
8Process validation
Time limits are not established when appropriate for the completion ofeach production phase to assure the quality ofthe drug product.
9Aseptic processing and sterility assurance
Procedures designed to prevent microbiological contamination ofdrug products purporting to be sterile are not established.
10Stability and storage
There is no written testing program designed to assess the stability characteristics ofdrug products.
11Equipment and facility
Equipment and utensils are not cleaned, maintained, and sani.tized at appropriate intervals to prevent contamination that would alter the safety, identity, strength, quality or purity of the drug product.
12Equipment and facility
Equipment used in the manufacture, processing, packing or holding of drug products is not of appropriate design and suitabl y located to facilitate operations for its intended use.
13Aseptic processing and sterility assurance
Each batch of drug product purporting to be sterile and pyrogens-free is not laboratory tested to determine conformance t o such requirements.
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.
