1Stability and storage
Results of stability testing are not used in determining appropriate storage conditions and expiration dates.
Inspection Record
Premier Pharmacy Labs Inc — FDA 483 Findings
Inspectors Joanne E King · Djamila HarouakaThe inspectors who signed the published document.Inspector lookup
View the regulator's official source The source document is always the basis for judgement.
Findings
2Labeling and packaging
The container labels of your outsourcing facility's drug products are deficient.
3Contamination control
You produced highly potent drugs without providing adequate containment, segregation, cleaning of work surfaces, cleaning of utensils and cleaning of personnel to prevent cross-contamination.
4Aseptic processing and sterility assurance
Aseptic processing areas are deficient in that floors, walls and ceilings are not smooth and/or hard surfaces that are easily cleanable.
5Aseptic processing and sterility assurance
Aseptic processing areas are deficient regarding air supply that is filtered through high-efficiency particulate air filters under positive pressure.
6Aseptic processing and sterility assurance
Aseptic processing areas are deficient regarding the system for monitoring environmental conditions.
7Deviation, CAPA, and investigation
There is a failure to thoroughly review any unexplained discrepancy whether or not the batch has been already distributed.
8Equipment and facility
Equipment and utensils are not cleaned, maintained and sanitized at appropriate intervals to prevent malfunctions and contamination that would alter the safety, identity, strength, quality or purity of the drug product.
9Aseptic processing and sterility assurance
Procedures designed to prevent microbiological contamination of drug products purporting to be sterile are not established, written and followed.
10Laboratory and QC controls
Laboratory controls do not include the establishment of scientifically sound and appropriate sampling plans and test procedures designed to assure that in-process materials and drug products conform to appropriate standards of identity, strength, quality and purity.
11Process validation
There are no written procedures for production and process controls designed to assure that the drug products have the identity, strength, quality, and purity they purported are represented to possess.
12Aseptic processing and sterility assurance
Aseptic processing areas are deficient regarding the system for cleaning and disinfecting the room and equipment to produce aseptic conditions.
13Aseptic processing and sterility assurance
Each batch of drug product purporting to be sterile and pyrogen-free is not laboratory tested to determine conformance to such requirements.
14Aseptic processing and sterility assurance
Aseptic processing areas are deficient regarding temperature and humidity controls.
About this record
Extracted automatically from the document US FDA published on 2020-03-09. 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.
