1Validation and qualification
There is no assurance that the ISO-5 <Redacted B4> is certified under dynamic conditions representative of routine operations (performed <Redacted B4>.
Inspection Record
Ideal Specialty Apothecary, Inc. dba Ideal Pharmacy — FDA 483 Findings
Inspectors Emmanuel J. Ramos · Nicholas Violand · Neda HamandiThe inspectors who signed the published document.Inspector lookup
View the regulator's official source The source document is always the basis for judgement.
Findings
2Aseptic processing and sterility assurance
Media fill studies are performed, but are not designed to stimulate routine processing.
3Equipment and facility
On 06/19/17, we observed condensation forming on two of the HEPA units on the ceiling of the production room, which was dripping on the cart containing the <Redacte d B 4>.
4Equipment and facility
Air handling design for the unclassified production room was observed to be inadequate on 06/19/17, in that the HEPA filters supplying air to the room are located adjacent to the returns, all of which are located on the ceiling.
About this record
Extracted automatically from the document US FDA published on 2025-06-20. 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.
